Hidden Gut Infections that Worsen Autism Symptoms

Our speaker James B. Adams, Ph.D., is the Director of the Autism/Asperger’s Research Program at Arizona State University. His autism research focuses on nutrition and gut health. He has published over 180 peer-reviewed research studies, including over 70 on autism. He is the President of the non-profit Autism Nutrition Research Center, President of Autism Diagnostics, and President of Gut-Brain-Axis Therapeutics. He has an adult daughter with autism.

Presentation Transcript

Hidden Gut Infections that Worsen Autism Symptoms-20260119_182924UTC-Meeting Recording
January 19, 2026, 6:29PM
1h 3m 11s

This is an unedited, uncertified transcript of proceedings. It should not be relied upon for verbatim citation. This document may contain computer-generated misinterpretations of spoken word, non-spoken sounds, or recording errors. Please refer to the video source for accuracy.

Yvette Bordignon (they/them) 0:17
So hello, good evening everyone and welcome. Thank you so much for joining us tonight. My name is Yvette and I’m the president of Neurodiversity Belgium. We’re really pleased to host this webinar on the hidden gut infections that worsen autism symptoms. It’s a real privilege to welcome our speaker tonight, Professor James Adams, Director of the Autism Asperger’s Research Program at Arizona State University, and a leading researcher in autism-related biomedical and nutritional approaches.

James, thank you for being with us tonight. We’re looking forward to learning from you this evening. Just so everybody knows this, if you have some questions coming up during the talk, please pop them in the Q&A at the top of the screen there and we’ll follow up with those at the end. So with that – over to you, James. Thanks very much.

James Adams 1:40
Thanks very much, Yvette, for inviting me to speak, and thanks very much to the audience for listening. Again, we’ll have plenty of time at the end for questions. So I’m a professor at Arizona State University when I’ve been doing autism research for over 25 years because I have a daughter with autism. I’m also the president of Autism Diagnostics, which is a company I founded because we’ve developed a diagnostic test for gut problems in autism. And then we’ve worked with the company Analutos to commercialize that test. And also we’re very focused on treatments.

So I do have to disclose some, make a few disclosures. I have several patents related to biomarkers and autism. As I mentioned, I’m the part owner of Autism Diagnostics in the lab to develop metabolomics tests for diagnosing and treating. Gut issues and autism have several patterns related to microbiota transplant and the use of probiotics for treating various conditions including gut issues and autism and Pitt Hopkins and I will be talking about a treatment microbiota transplant therapy. This is an Investigational treatment. We’ve conducted several clinical trials, but it’s not yet approved by the FDA for autism. That’s why we’re doing the studies to try to get it approved.

So as many of you may be aware, roughly 40% of children and adults with autism have obvious chronic gut problems. Constipation, diarrhea, bloating, pain, sometimes reflux, and these symptoms often can last for many years or even decades. We’ve discovered from our research these GI symptoms almost always begin in infancy and continue a long time. We published a study 15 years ago. There have been several similar studies showing that worse gut problems are associated with worse autism symptoms.

So what’s causing these gut problems? So we’ve discovered that these problems seem to be primarily due to bad gut bacteria and yeast. As I mentioned, we published a paper 15 years ago showing these gut problems strongly correlate with autism severity. The worse the gut problems, the worse the autism symptoms.

And our paper has been cited by over 1000 different research groups. There’s been a lot of interest in this topic, so it helps to understand what is the role of the gut bacteria and yeast in our gut.

Our healthy person has very healthy gut bacteria. They’re very important for helping you digest your food, and they also help produce certain important vitamins. Also, when your body consumes fiber, the gut bacteria help. Produce butyrate from it, and butyrate is the primary nutrient for the cells that line the gut. So many people are not consuming enough fiber, and that’s literally causing those cells that line the gut to be starving for their major nutrient.
Our healthy gut bacteria also help with water balance, so your stool isn’t too hard or too soft. They also help regulate the immune system and they help prevent pathogenic bacteria from growing. Unfortunately, many people also can have pathogenic bacteria that can damage.
The intestines in severe cases, they can cause a major damage, bloody diarrhea. They can cause major gut problems. They produce toxins which can affect brain function, and we’ll talk more about that. They can disrupt the immune system and they compete against the beneficial bacteria.

So a little cartoon saying we are not alone. Human Gut Microbiome Project say estimates we have about 100 trillion bacterial cells in our body, about as many cells as you have human cells you have in your body and they’re all crowded there in the gut. The microbiome has major effects on the health of the gut and the brain. Beneficial metabolites produce bile acids, very important for digestion, the butyrate I mentioned for feeding the gut and key vitamins like biotin and vitamin K and those metabolites and go on to help benefit the whole body, including the brain. But unfortunately we now know that in autism these gut bacteria can produce many harmful metabolites, and I listed some of them here and they can leak out of the gut and affect brain function and cause neuroinflammation.

There was a study 25 years ago in which they examined the effect of long-term antibiotic therapy. So eight weeks with a very special, very powerful antibiotic called vancomycin led to great improvements in gut symptoms, great improvements in autism symptoms.
But when the treatment was stopped, within a few weeks, those benefits were lost. So that suggests that those harmful bacteria just grew right back, and it suggests that there’s a need to then reseed the gut with beneficial bacteria to prevent the regrowth of those harmful bacteria.
We now know that roughly 90% of children with autism have extremely high levels of some very toxic metabolites from gut bacteria or yeast. One example is p-cresol sulfate. 17 studies of it for autism. Every study shows it’s elevated in children with autism compared to typically developing children. We know the more of it you have, the worse the autism symptoms. We know it’s toxic to the gut, the body and the brain in many ways. And this is just one of many metabolites that we’ve now identified. The bottom line is that almost every child with autism has one or more of these metabolites, sometimes picresol, sometimes other metabolites, at very high levels.

So we published a review paper almost a year ago on reviewing the links between pecresol and autism and how it affects the body. This is a brief summary that in the gut it acts as an antibiotic to kill off other competing bacteria and it also damages the gut, causing leaky gut, so that it’s easier for waste products from the gut to leak into the body. In the brain, it affects neurotransmitter function, especially dopamine function. The mitochondria, which are the major energy producing factories for the body. It it disrupts their function so they produce less energy for the body and brain and also creates more oxidative stress.

Which is many studies have shown is a major problem in autism in the liver. The liver converts p-cresol into p-cresol sulfate to get rid of it. But roughly 90% of people with autism have a sulfate deficiency, so it takes them more time to get rid of the decrease all in the kidneys, it’s been known for decades that picresol is a nephrotoxin. It’s highly toxic to the kidneys. The more of it you have, the shorter you have left to live. It’s very damaging to the kidneys at high levels and causes or is associated with chronic kidney disease.

In the immune system, it makes it harder for the immune system to detect infections and harder for it to fight infections and most relevant to autism. There have been several studies of administering P-cresol to mice. And when they do, those mice begin developing autism. They separate from one another. But if they get a fecal transplant from a healthy mouse, they lose their autism symptoms and begin socializing together again. But if you take the gut bacteria from those mice treated with p-cresol.

And put it into other mice, then it causes autistic symptoms again. So it’s clear that the p-cresol causes bad gut bacteria and causes these autistic symptoms, which can be recovered. By microbiota transplant from a healthy mouse. And so if it works in mice, that’s why we’ve been investigating in humans. But pea creosol is just one of metabolites we’ve identified. We’ve now through our extensive lit review identified 49 studies. Of 11 different metabolites, which are much higher in children with autism compared to typically developing children, and you can detect it with a simple urine test. So the asterisks here are metabolites that are derived from either phenylalanine or tryptin. These are the building blocks for two important neurotransmitters, serotonin and dopamine. So basically, these gut bacteria and yeast produce corrupted versions. Of dopamine and serotonin, which has big effect on mental function. Those two neurotransmitters are very important for affecting many mental health symptoms, for affecting learning and attention and emotion regulation and overall happiness.
So we’ve completed a study of 50 children with autism, 48 typically developing children, ages 2 to 11. We measured over 40 different microbial metabolites in the urine. We found 32 were significantly higher in autism versus typically developing children. Many of these had never been measured, so we still confirming the identity of all of the 32, but basically they’re almost all of them are modifications of phenylalanine or tyrosine.

Which affects dopamine, noradrenaline and adrenaline metabolism, or tryptophan, which goes on to make serotonin. And then serotonin is converted by the body to melatonin, which regulates sleep. And so we think this is one of the reasons why most children and many adults with Autism have sleep problems because they have corrupted versions of melatonin from these gut bacteria. Many of these metabolites are known to be very harmful, and the rest are highly suspect, but they’re clearly biomarkers of a major gut problem. And so alterations in these neurotransmitters likely affect your cognition, your ability to think, affect your attention, or ADD. They affect your mood, so your anxiety, your irritability, your aggression, and affect sleep.
So this is just one example of one metabolite, beta-carboline that’s produced by yeast. The Y axis is the level of the metabolite in different people. The blue squares are typically developing children. The red triangles are children with autism.

The 1X is the average level of these of this metabolite in typically developing children, and you see they’re all generally in the bottom half of this graph. This is a log scale and we see these red triangles above the roughly 10 times we have children with autism with levels of these metabolites at 50100, even up to 1000 times higher than that of typically developing children, higher than that of any typically developing child. And this is a very harmful yeast metabolite of that. Basically interferes with tryptophan function and then serotonin and melatonin metabolism. So for each metabolite, I won’t show all the others, but for each metabolite there’s a subset of children with autism who have unusually high levels of that particular metabolite.
So what we’ve done is put it all together and counted up how many metabolites are extremely elevated in children with autism.

So let’s start with cohort one on the left, 50 children with autism, 47 typically developing children we looked at a subset of 15 metabolites. The blue triangles. The blue squares on the bottom are the typically developing children. By definition, they all have levels of all 15 metabolites, all within the normal range.

But the kids with autism, almost every one of them has at least one up to 9 different metabolites at levels above that of any typical child. So this is a screening test we can use to early on.
Diagnosed who is at high risk of being a child with autism. It’s 90% sensitive, meaning 90% of children with autism have these very elevated levels, and that’s 100% specific, meaning that none of the typically developing children we measured have elevated levels. We then did a second study with a new group of children, 42 children with autism, 17 typically developing children, and we found the same thing with a separate lab.

And so again red triangles show most of the children with autism have very high levels and none of the typically developing children have elevated levels. So again, very accurate test in diagnosing these gut problems in children with autism. And notice there’s not much change with age that we’re plotting versus age from age 2 to age 18, and the levels are roughly the same for young children versus older children.

Now, out of those, there were five children with autism who did not have these extremely elevated metabolites, and we discovered that three of them had major errors of metabolism that are likely genetic. So I label those three specific disorders that they had here.

So bottom line is that there’s maybe 10% of children with autism who have a major single gene disorder not associated with a gut dysbiosis, but 90% of children with autism seem to have this major gut dysbiosis.

So we are boldly proposing a new autism phenotype based on our measurements of these microbially derived metabolites. So this definition is unusually high levels of any of these microbial metabolites that are derived from tryptophan or phenol island and hence are likely to affect serotonin and dopamine function. When we use the full set of metabolites, there’s an average of about 7 that are elevated in each person. Some we know primarily affect only brain function. Some we know affect both gut and brain function.

A simple example that you’re probably all familiar with is if you’ve ever gone to the bar for a drink. Alcohol is produced by yeast, and yeast in your gut produce a little bit of alcohol, but also much, much worse toxins. And so, in the same way that alcohol can have a big effect on brain function, these metabolites produced by yeast or bacteria in the gut can also have a big effect on brain function. And so a simple way of saying it is that many people with autism are.
Drunk on these toxic metabolites from their gut, and by getting rid of those metabolites, we hope to see improvements in their symptoms and happiness. So there’s very high variability in which metabolites are elevated in each person. Some people high in one, some people high in another.

But roughly 90% of people without with non-syndromic autism have elevated levels. There’s been one study in autism we did using microbiota transplant. I’ll talk more about it later, showing that we could decrease levels of peak resil sulfate down to normal.
So just to conclude this part of the talk, we know that roughly 40% of people with autism have obvious gut problems, Constipation, diarrhea, gut pain. But we’ve now discovered that most of the rest have hidden gut problems with the only symptom.

Worse autism symptoms, more problems with sleep or cognition or mood. And so 90% of children with autism have these elevated levels which affect again serotonin and dopamine. So they affect cognition, attention, mood and they affect melatonin, so they affect sleep. It also explains a very high rate of chronic kidney disease and Parkinson’s in adults with autism, because p-cresol is elevated, very elevated in people with chronic kidney disease.

And Parkinson’s disease is a disease of dopamine, and peak Riso levels in the brains of people with Parkinson’s are roughly 8 times higher than that of typical people. So we know that these metabolites don’t only affect autism, but also affect chronic kidney disease in adults and Parkinson’s in adults. Some of these metabolites like P-cresol cause autistic symptoms when given to mice and correlate with autistic symptoms in humans. So we now have developed this test and I’ll tell you more about how we’ve commercialized it. But again, we’ve proposing this phenotype. There’s a subset. Most people with autism follow into this subset where they have high levels of these metabolites. They’re affecting their brain function and often affecting their gut symptoms.

And our treatment seems to be able to reduce the levels of at least one of those down to normal and soon we’ll have results on the rest. So let me move to the second part of our talk, which is how do we test for these infections?
So we’ve worked with a lab called Analutos. It’s a laboratory in the United Kingdom and we develop a test with them. So testing for these infections in the gut is very complex because you can’t see inside the gut, you can’t see. What’s going on in the gut? You have thousands of different possible bacteria and yeast in the gut. Many are beneficial. Some are harmful. Some are beneficial at low levels, but are harmful if they get too high. It’s very unclear which species or even strains are producing the toxic metabolite.

You can have a Clostridium difficile infection and if it’s the non-toxic form you’re fine, and if it’s a toxic form it can be fatal. So the best option we believe is to test for what they actually produce. Which is these toxic metabolites tells you that if the toxins have left the gut, entered the body and then are being peed out in the urine. So we developed a test which we filed several applications for, patent applications for. It’s a spin-off company from by university and we’ve been collaborating with the commercial company Analutos for several years to commercialize this test and make it available to everyone. And so we call it the combined gut health test from Analutos.

It’s a very simple urine test. You just need to collect a urine sample, freeze it and ship it. We have a special preservative, so it even if it thaws, it’s stable for over a week. Any family can go to the Analutos website and order the test. A test kit to be mailed to them. The test measures the levels of toxic metabolites from yeast. So we have 3 biomarkers for yeast. We also measure toxic metabolites which come from the bacteria. So either those that are dopamine related or serotonin or melatonin related. We also measure the precursors to those amino to those neurotransmitters, so tryptophan, phenolal and tyrosine.

And then Analutos has been investigating for over 20 years gluten and casein peptides. Many people with autism have intolerances of those. One of the reasons is they may not. They often lack the ability to digest. Those molecules and break them down into individual amino acids that are harmless. So our test also looks for those gluten and casein peptides, and if they’re present then it means your body can’t digest gluten or casein very well and you should go on a gluten free or casein free diet.

There can be other problems with gluten or casein. It can cause allergic reactions. That’s not what we test for. We test for the body’s ability to digest those. So how do we interpret the test? So it’s roughly 89% accurate in screening for autism, so in very young children, if you’re suspicious a child may have autism symptoms, let’s test for it early on to see if they’ve got dysbiosis. With the commercial version, roughly a 78% of children with autism test positive for a yeast infection or a bacterial infection, or sometimes it’s both.

Compared to none of the typically developing children. So it lets you know if the yeast or bacterial toxins are present, and then that tells you which type of treatment is going to be more effective, more helpful. It tells you about the level of neurotransmitter precursors. Are you getting enough in the diet? Is there a problem with their metabolism by the gut bacteria? And again with gluten and casein peptides, it tells you if you have a problem with your diet.
So the advantage of of this test is it uses state-of-the-art equipment, what’s called liquid chromatography, mass spectroscopy. We have excellent pediatric reference ranges for healthy, typically developing children.

The test is led by two experts, each with 20 years of over 20 years of autism research experience, and the test is now available from anywhere, almost anywhere in the world. They have a deal with FedEx so that that we can that way they can easily ship Test kit by FedEx to anyone in almost any part of the world and then easy to get it back to them. So now I’m going to go to the third part of my talk, which is after testing, how do we go ahead and treat these gut problems? So why? First of all, why is it that 90% of people children?

With autism have these very elevated levels of toxic metabolites. One of the major reasons is, especially during infancy, exposure to antibiotics which kill off your normal bacteria, herbicides and pesticides in food and at home can affect them. Inheriting poor gut bacteria as an infant. A low fiber diet. Not getting enough vegetables, fruit, beans and whole grains. Just not getting enough fiber. Fiber is so important for a healthy gut. A limited variety of foods if people are picky eaters. And some people with autism have reduced levels of digestive enzymes, especially lactase. That’s the the enzyme needed to digest lactose, the sugar and milk. So bottom line is that all of these are factors that can contribute to gut infections.

Which can then lead to the harmful gut bacteria and yeast producing toxins that affect the gut, the body and the brain. They interfere with those key neurotransmitters and affect cognition, attention, mood and sleep. So there are some standard treatments for gut problems, improving the diet, especially a more varied diet with higher fiber. For some people, digestive enzymes, especially lactase if you’re lactose intolerant. Fiber supplements can help some, but we think the best way to get fiber is from a variety of fruits and vegetables, because there are many types of fiber, so you want to get a wide variety, not just a single type of fiber. Probiotics may help a little bit.

Unfortunately, a meta-analysis of over 10 studies for probiotics show they don’t seem to help gut symptoms very much. Maybe they have a small effect on autism symptoms. Laxatives are important to keep to prevent constipation. You’d really ideally like to have at least.
One bowel movement a day. The longer the longer the stool stays in the gut, the more toxic metabolites are being produced. So in the same way, if you’re brewing beer or wine, the longer you brew it, the more alcohol is produced, the longer the stool stays in the gut.

The more toxins are produced. You want to try to have a bowel movement each day. If people are very constipated, enemas can be used temporarily. We don’t recommend them long term. Same for suppositories. If someone has diarrhea, there are some anti diarrheas that could be considered but diarrhea is generally your body’s defense against how to flush harmful things out of your gut. So really, you want to try to figure out what in the diet is causing the problems, or the gut infection can be causing those problems.

Antacids can help with stomach acid, but we’ve discovered that if stomach acid and heartburn, excess stomach acid leading to heartburn and acid reflux seems to be largely due to constipation, so reducing the constipation seems to help. Exercise very underrated, but very important. The more you move your body, the better motility you have. If you’ve been lying in bed in a hospital bed for a week, you’re going to be very constipated from lack of movement. So movement’s important.

But unfortunately, all of these standard treatments are generally treating the symptoms but not addressing the root cause. What we believe has occurred is a bacterial yeast infection early in life that can last for many decades and is very hard to treat. So the advanced treatments we’ve looked at, we’ve developed a vitamin mineral micronutrient supplement available from a nonprofit I formed 13 years ago. That helps with many aspects of body functioning and helps a little bit with gut symptoms specialized diets. I’ve given a talk and we published a paper analyzing 13 different diets based on survey data of over 1000 autism families. So different diets can help with different aspects.

We’ve investigated customized probiotics, which seem to help a little bit. Most importantly, if you have a yeast infection, antifungals can be very helpful. And then microbiota transplant, which I’ll touch on very briefly, but that’s a treatment which we developed. It’s not yet commercially available. But we found that by replacing harmful bacteria, beneficial bacteria, just like I talked about in the animal studies, it worked very well. It also has worked well in several of our studies for children and adults with autism. So our theme is heal the gut and that appears to heal the brain and help people. People just have happier lives. So what is microbiota transplant therapy? It’s an investigational therapy not yet approved by the FDA or the EU, but we’re trying to do that. We’ve completed 4 successful clinical trials for autism and a related condition called Pitt Hopkins.

We’re currently conducting 2 more clinical trials. We’ve observed up to 80% reduction in gut symptoms. On average, we see severe autism symptoms being reduced to mild to moderate symptoms. Language improves, behavior improves. Most importantly, happiness improves.
And benefits lasting usually two or more years. I formed because of the success of our first four studies. We then formed a company, Gut Brain Access Therapeutics to fund clinical trials, the next stage of clinical trials to get it approved. So now we have I need to update this slide.
It’s now over 120 autism families have chosen to invest in our company and fund it and we’re now continuing to raise more money to finalize our to conduct our final phase three trials to get it approved. So what is our treatment? It involves 3 steps first two weeks of a special antibiotic vancomycin, as I mentioned earlier, we need 25 years ago temporarily helped. But then we do one day of a bowel cleanse, just like you’d have for a colonoscopy preparation to really flush out the bowels, remove as much remaining stool and gut bacteria is possible. I forgot to mention that roughly 1/3 of a person’s stool is gut bacteria. So if your stool looks abnormal, smells abnormal, it’s pretty certain you have some bad gut bacteria or yeast there. And then after the bowel cleanse, once you removed as much as possible.

The original gut bad gut bacteria. Then we dose daily for 8 to 16 weeks with either capsules you can just swallow or with a powder that you can just mix with a little bit of milk or yogurt and swallow it that way with an antacid. This microbiota comes from very healthy human donors. It contains over 400 species, unlike typical probiotics that are just one to 10 species usually, and we’ve shown that when we stop treatment, these benefits can last a long time.
So just to give you an example from our first study, we found that microbiota greatly improved gut symptoms. This is a plot showing the gut symptoms at the start of treatment. At the end of treatment, 16 of 18 children had very large reductions in GI symptoms. We waited 8 weeks and checked again. Now 17 of 18 children had improved their gut symptoms and then two years later we checked and most of the improvements were still holding, but one person that had antibiotics and lost people benefit.

Some people were on poor diets, but most people had improvement in GI symptoms long term. And then if we look at autism symptoms, even more improvement. At the start of the study, it was roughly 80% of people were in the severe range.
At two years post treatment, less than 20% were severe, 40% mild to moderate, and roughly 45% below the cutoff for even mild autism. They still had some symptoms, but overall much better language.
Social interaction, behavior, and just a lot happier. And this treatment is very safe. We’ve now treated over 100 children and adults with autism, 0 serious adverse effects. So then we received a grant from the federal government, $1,000,000 grant to do a study for adults with autism.
This is what we call randomized double-blind placebo-controlled study. We enrolled 56 adults, 51 completed. Again, we found the treatment is very safe. We even had fewer and less severe adverse effects in the treatment group than placebo.
We found it was very effective, medium effect size after 10 weeks. When we treated longer, there was even more benefit. NGI symptoms again improved as well. We’re still working on optimizing the dose. We think that higher dose may result in even more benefit.
But just to give you an idea, the Green Line is a treatment group. This is a plot of what’s called the Childhood Autism Rating Scale. 15 is the lowest possible score. Roughly 30 is the cutoff for autism.
3534 to 35 is a cutoff for severe autism. So we see at the start they started. The treatment group started in the severe autism range. After eight weeks of treatment, they improved some. Another eight weeks of treatment, they improved more.
And then following up with them six months, 12 months and 18 months after treatment had stopped and they were now on average down in the mild to moderate range. We had a placebo group. They didn’t change much at first until then we gave them eight weeks of treatment, but without the vancomycin.
Because the FDA wanted to see was the vancomycin needed, we followed them for 6/12 and 18 months and what we found is that eight weeks of microbiota without vancomycin was not as beneficial as 16 weeks of treatment with vancomycin. So this helped us see which treatment was most.
Code was more beneficial in terms of the exact symptoms which improved. This is a plot showing the percentage improvement in the symptoms. So tantrums and or irritability improved 70% in the treatment group versus 25% in placebo shown in orange.
Also big improvement in GI symptoms and aggression, hyperactivity, mood, self injury, sleep, sensory sensitivity, stimming and more. It’s not a cure, but it’s a substantial reduction in these problems.
And you see that some symptoms improved more than others, but on average we saw every symptom the treatment group improved more than placebo on every symptom.
I’ll just share with you a couple of quotes from families, one family reported. I felt the treatment was foundational for my son. He seems happier, more well adjusted. He’s less anxious, less OCD.
Troublesome behaviors and outbursts are much less frequent, less intense. He’s sleeping much better, and his daily bowels are regular and normal, another family reported. My son, age 30, ADD and autistic. He’s always had GI problems since he was a baby.
The study was a miracle for him. No more pain. This is more than we could have hoped for. And there’s a bonus. His depression and anxiety levels are way down, and the most common symptom we hear from families is just their child, their adult is much happier.
So we’re now working on getting this treatment approved by the FDA. We’ve done two studies for a very rare condition called Pitt Hopkins. We hope the second study will be enough for drug approval for Pitt Hopkins. We’re now doing a study for doing studies for autism. We’ve completed three studies for autism.

We’re now doing a fourth study, a dosing study. Once we know what dose is optimal, then we hope later this year to be able to raise enough money to do our final phase three study, which then we hope would be enough for us to apply for FDA drug approval so the treatment could.
Be available in the US and eventually available throughout the world. So again, our company is a very unusual company funded by autism families to help people with autism. We’ve already raised 8 million from over 100 families.

That’s sufficient for our current studies and now we need to raise 20 million for our final studies. It’s potential for very high profits for investors. If you want to learn more about it, you can go to our website gutbrainaccestherapeutics.com. And that can tell you more about it. If you’re interested in learning more about the company or interest in investing, feel free to e-mail me. But just to summarize, the three main things I want to cover is we’ve discovered and they’re over now.

Over 50 studies backing us up. Roughly 90% of children with autism have very high levels of microbial metabolites from gut bacteria or yeast. Most of them affect dopamine or serotonin function and melatonin in animals, it’s been shown that they we can recover their autistic symptoms after they’ve been treated with these by microbiota transplant. In terms of testing now, Analutos is offering the test. Anyone, anyone, almost anywhere in the world can.
The test from Analutos and check to see if you need help interpreting the test. Our nonprofit has a consultant who can help you with interpreting the test and we also have publications which you can refer to. And then in terms of treatment, I’ve mentioned a number of standard treatments for gut symptoms and some advanced treatments. We’re especially excited by the microbiota transplant therapy because it’s replacing those harmful gut bacteria with beneficial bacteria.

So we have more information at our websites Gut Brain Access Therapeutics or if you’re interested in a test, it’s available from Analutos. Or if you want to learn more about our research, you can go to our university website autism.asu.edu. And I want to acknowledge the many, many autism families and Pitt Hopkins families and 1000 plus families who’ve donated to our research, many groups who’ve provided us with funding. Many families who have invested in gut brain Axis Therapeutics, the many people on a research team and I’m only have space to list some of them and our colleagues at University of Minnesota who make these wonderful products for us.

And the team at Analutos who’s worked hard for several years to get this test commercially available. So again, if you have questions, we’ll have a question and answer period. Now. If I don’t have a chance to answer your question or if you have a personal question, you can e-mail me and you can also go to our Website. So with that, thank you for your patience and now we’ll turn to the question and answer part. So let’s see.

Yvette Bordignon (they/them) 42:45
Jensi is okay to.

James Adams 42:45
I think I have to go to stop sharing. And then we’ll go to Q&A. So please feel free to type in any questions into the Q&A and I’ll do my best to answer those as we go along. So one question is since the MTT approval for autism is envisioned for late 2028.

What other interventions do you recommend? And do you have consultants that you can advise? So I did go through quite a list of other interventions that can be done now, so I can jump back to that if you want, but again, those.

Most of those treatments are temporary treatments for treating the symptoms. We think the underlying problem is these yeast or bacterial infections. So if you get a positive test result from Enerlutos for a yeast infection, we recommend antifungal therapy.

Interestingly, there was a survey done by the Autism Research Institute of 23,000 families asking them what were the most effective treatments for autism symptoms, and the two most highly rated treatments were the two antifungals, nystatin and diflucan, those are the two most highly rated treatments based on reports from 23,000 families. So the unfortunate thing is that those antifungals, after you treat with them, the yeast often comes back again and again. I could explain more why that is.

But the antifungal therapy seems to be needed to be used for a long time, usually with a change in diet to remove sugars and starches that tend to feed yeast. So that’s one of the major issues.
And then if you have a bacterial infection, if that’s identified, changing diet is important. Trying to have a bowel movement every day so those bad gut bacteria don’t stay too long in the gut. Those are some of the most important things.

Fiber supplements may help, but more with preventing the problems and treating the vitamin mineral supplement I mentioned from our non-profit has been shown in several clinical studies to help somewhat with gut issues. It helps more with overall brain and body health, but it also helps with that. And then after you get a test result from Analutos, we have our non-profit has consultants. It’s roughly $40.00 for 1/2 hour consult and they can help explain the test results. Next question is since the Analutos MDM test is for children only.

How can adults test? Adults can also use the test. We now are establishing a reference range for adults as well. So I didn’t mention it, but we’ve done a study for adults as well with this test and we found that roughly 75% of adults with autism, not quite as many as children.
Some of them can their gut symptoms can improve over decades, but roughly 75% of them seem to have these lingering gut issues as well. The reference ranges are a little bit different for adults, so we’re still working on finalizing those reference ranges.

But again, our test results will let you know pretty clearly if there’s a major difference or not.
Next question is before MGT is available, can some treatment or diets be effective to specific results from the test? Well, I did go back, I did mention that maybe I should share my screen again just briefly.

And I’ll jump back to that slide and I’ll just show it again.

And again, this talk is being recorded, so you can go back to this, but feel free to take a screenshot or a picture. But these are the treatments on the left that are likely to be beneficial. Improving the diet, often feeding the same food over and over again, that’s a problem, but generally eating more.
Vegetables, more fruit and we recommend whole fruit. So not drinking orange juice, but eating a whole orange because that has the fiber in it and is better for you. So whole grains who have high fiber.

Beans and legumes are good sources of fiber, so overall improving the diet, reducing amounts of junk food, reducing sugar and starches. Some people with autism need digestive fibers. You can use fiber supplements, but again, we think it’s better to get your fiber from fruits and vegetables? A great way to do that is by just taking a bunch of fruits and vegetables, putting them into a blender and just blending it up with the pulp. So you want to get the pulp as well and just making a fruit smoothie with vegetables in it.

Probiotics. Again, the the research is mixed. There are a lot of probiotics out there, but probiotics generally are species that grow in milk. They’re not generally the species that grow in your gut, and they may help temporarily. Each person is a bit different.

Yvette Bordignon (they/them) 48:04
Thank you.

James Adams 48:13
But again, we need a lot more research on them to see. We did a large study with a customized probiotic from a company called Florey and that had some modest benefit and that is now available commercially. And I think I talked enough about the other treatments here, but I’m happy to answer any more specific questions about those.

So let’s see. Next question is when do you think MTT will be available commercially? We hope it will be available for Pitt Hopkins in about a year and a half, but for autism, it’s not a rare disease, so the FDA requires many more studies.

Yvette Bordignon (they/them) 48:44
Yeah.

James Adams 48:57
So provided we can raise the 20 million, we hope to apply to the FDA in 2028 and it’s about a one year review process. It would be about 2029, about three years from now at the soonest if all goes well.

So we’re doing all we can, but the FDA has very strict guidelines on approving treatments and they view microbiota transplant as a drug. The good news is because it’s has such a good safety record, it seems likely the we have a small, relatively small number of people will need to.
Role in our studies. Next question is if you’re actively doing FMT, when should you get the Analutos test done? Well, again, FMT is experimental, so I’m not advocating you do it, but we recommend doing the Analutos test to see if you have a gut infection that needs treatment and if you’ve been treated, after you’ve been treated, we recommend doing it again at the end of treatment or several months after treatment. You can do both, but we find that there’s some improvement at the end of treatment in the test.

Even more improvement, usually three months later, it takes a while for the gut bacteria to adapt to the host and adapt to their individual diet, because your diet has a very big effect on your gut bacteria. It’s the food for them.

And so as you and when you change your diet within a few days, your gut bacteria will adapt to that change in the diet. They’ll shift which ones are present. And so usually we’d recommend doing it after any treatment and a few months after the treatment to see if it’s been beneficial.
We’ve observed that we’ve seen a decrease in metabolites, but we think we may have been under dosing. So we think we may have needed a higher dose or a longer treatment and so the treatment can help you know that.

Another question is any specific points for people who have done a full gastric bypass surgery? Oh wow, yeah, my colleague Rosie Krojmalnik Brown has done a study of the gut microbiome in people who have done.

A full gastric bypass surgery. Let me just make sure I see all this question. Um.
So people who have done a full gastric bypass surgery have, generally speaking, a more reduced a fewer species in their gut and are probably more prone to gut issues.

If someone was autistic or ADHD and did that surgery, yes, we believe they’d be more at risk of gut bacterial issues and so they we’d urge them to be very cautious about the use of antibiotics.
You think that’s one of the major contributing factors in making sure they get enough fiber in the diet? Let me be very blunt about fiber. In America, the average the estimate is women consume only half the recommended amount of fiber on average.

Men are worse, and we consume only about 1/3 of the recommended fiber. So we just need to be eating a lot more whole fruits, whole vegetables, whole grains. Those are very important foods and so really making sure you improve the diet as much as possible, avoid antibiotics and also pesticides and herbicides are also a substantial concern.

Another question I’d like to ask what documented risks are associated with microbiota transplant in children, and especially those associated with the increased intestinal permeability. So we’ve treated over 100 people with microbiota.

A transplant at children and adults with autism and Pitt Hopkin Syndrome. We found that they can be temporary symptoms of the first few days after a bowel cleanse. You may have softer liquid stools, just a lingering effect of the bowel cleanse. People with autism have their good days and bad days with GI symptoms and autism symptoms. We found that those in our treatment group had fewer and less severe adverse days than the placebo group. So we saw fewer and less.

Severe adverse effects than placebo. In our first study, the treatment was so well tolerated everyone who started the study completed the study. In our second study, for 56 adults with autism, no one dropped out of the study due to an adverse effect.

In our study for 50 children with autism, we had only one dropout due to a worsening of behavior, and they dropped out. They were in the placebo group. Their behavior worsened, but no one in the treatment group dropped out.

So in general, we have very high completion rates. The treatment’s very well tolerated. The group that makes our product at the University of Minnesota, they’ve treated over 8000 patients with over a dozen different conditions.

And they have seen zero serious adverse effects due to the treatment. But yes, you could see temporary changes in gut symptoms or autism symptoms as the gut bacteria change quite a bit, but usually any adverse effects or any symptoms usually.

Just for a few days, but sometimes can be longer. So I hope that answers the question. Next question is, does this research distinguish between the different levels of autism? So.
We accept anyone into our study who has a diagnosis of autism, even mild autism, and also, but they also in our treatment studies, we’ve limited the treatment studies.
To people with GI issues. So for our anneludos test, we admitted anyone with autism, any severity. But for a microbiota transplant therapy, we required they have at least some modest GI symptoms 5 days out of 14.

Where there was some abnormal pain or abnormal bowel movement. And so on average, most of the people in our studies have been with severe autism, but even the people with mild autism improved as well. Generally, the people with mild autism dropped below the cutoff for autism.

Those with severe autism drop down to mild to moderate autism, generally a little bit more improvement for the children than the adults, it seems. But again, we have more research to do. It could be the children just need a higher dose, and that’s why in our dosing study we’re going to higher dosages.

Another question about probiotics from Flore. Is there an ETA to start ordering? The Flore product is available. They in our study we used a customized version where it was customized for each individual person so they would measure the.
Bacteria of each person and then mix a create a mixture of typically half a dozen probiotics and prebiotics specific for that person. Companies no longer doing that, it was just too expensive to do.

But they now have developed an average probiotic based on the research study we did. It hasn’t been formally studied, so we would like to see a lot more research to see which probiotics might be beneficial.

I think the important thing to understand is that people with autism have very, very different gut bacteria. The latest study suggests that people with autism, an average person, has about 400 species of bacteria in their gut.
On average, children with autism are missing over 100 of those species. Some children are missing these 50, other children are missing these 50 or 100. It’s very different from one child to another. That’s why we like microbiota transplant, because you’re getting 400 of order 400 species from a very.

Very healthy person. So regardless of pretty much regardless of which ones you’re missing, we’re able to provide pretty much all the ones you need. And the studies also show that children with autism have roughly 500.

Bacteria that are elevated in people with autism. In fact, some have been 1 bacteria was named after the mother of a child with autism because it’s was first found only in children with autism. So I hope that answers the question about Flore.

So I think in general you can try different probiotics. If one doesn’t work after a month or two, try another and another and another at the moment. Unfortunately, it’s just trial and error. For the most part, this data does suggest slightly more benefit with multiple strains.
Than with a single strain, but again, it will be different for each person. And finally, last question, with the assumption of identifying the bad bacteria through testing, would the use of antibacterial medicines or herbal options help reduce symptoms?

Unfortunately, on average, no antibiotics generally seem to worsen symptoms. So I mentioned this study by Autism Research Institute of 23,000 families, the top two rated treatments with the two antifungals nystatin and diflucan. On the other hand, antibiotics were much more likely, much more likely to worsen symptoms than to improve symptoms. So generally, we do not recommend the use of antibiotics by themselves. We only use them very temporarily.

As part of MTT to remove the harmful bacteria. But as I said, if we stop there, they’ll just come back. And if you keep doing it, you’ll kill off more and more of the beneficial bacteria each time. So we think overuse of antibiotics during infancy is a major problem. There are many studies by our groups and others showing one of the major differences in medical histories of kids with autism is high use of antibiotics during infancy, especially for ear infections. Again, we recommend to not use antibiotics for most cases, they tend to worsen symptoms, much more likely to worsen symptoms than to improve them, unless you’re working with a really expert physician who has a really good understanding of the specific bacteria they want to target. But there’s been no antibiotic study published yet that I’ve seen that has shown a long term benefit, just temporary benefit in the vancomycin study and then benefits were lost. So I think that’s all the questions. I think I’ve tried to answer them all.

If anyone has more questions, feel free to e-mail me them, e-mail them to me and again, I’ll just put in my I should put in my short e-mail. james@gbat.com is the short one.
And so feel free to e-mail me there if you have questions or if you want to learn more about our research or about investing in our company. But Many thanks to Yvette and the Neurodiversity Belgium group for organizing this. I ran an Autism Society of America organization.
Organization for 20 years. It takes a lot of work to run a nonprofit and to provide advice to families. So three cheers to Yvette and Kate, who led it before her for the years of work they’ve put into it. And please thank them for hosting this webinar.

Yvette Bordignon (they/them) 1:01:38
Yeah.

James Adams 1:01:46
And for recording it.

Yvette Bordignon (they/them) 1:01:48
James, thank you so much. Really, not only is your research and expertise, but also the commitment and care you bring to the work as well. We have to remind ourselves, especially with someone personally affected by all of this myself, your contribution really helps bring visibility to an important and often.
Overlooked topics, especially in our community. So that was truly informative and thought provoking talk and we really appreciate sharing all of this time and answering all those questions, your knowledge and your findings with us this evening and to everyone who joined tonight.

Thank you very much for your time, your attention, and for being part of this community. If you’d like to stay connected with Neurodiversity Belgium, we run peer support groups, community events, regular webinars like this, and we’d love to welcome you into our network.
Please keep an eye out for the up and coming Events and next webinars, which we’ll be sharing very soon. You’ll receive a recording and yeah, any questions. As James said, he’s very, very generous with his time. Thanks very much again, James.

And to everyone else, thanks again. Wishing you a lovely, calm evening. Good night.

James Adams 1:02:57
Thanks very much.

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