Autism/Asperger's Research Program

Microbiota Transplant Therapy (MTT) and the gut microbiome: 

MTT for Autism:  About 40% of children and adults with autism have chronic gastrointestinal disorders such as constipation, diarrhea, bloating, reflux, and gut pain.  These disorders are often due to abnormal gut bacteria.  We developed and patented an intensive version of MTT for autism, and our first study demonstrated an 80% reduction in GI symptoms and initially a 23% reduction in autism symptoms.  In a follow-up study 2 years after treatment was completed, most GI symptom improvements remained, and our expert evaluators reported a 47% reduction in autism symptoms compared to baseline.  This was an open-label study, so there was some placebo effect.  Measurements of the gut microbiome also demonstrated good improvements at end of treatment, and even more at 2 years post-treatment.

We have now completed the treatment portion of our Phase 2 study for adults with autism, and expect to complete the treatment portion of our Phase 2 study for children with autism in August 2023.

MTT is an investigational treatment, and we hope to raise funds to conduct Phase 3 studies (the final stage for FDA approval). 

News article on our research on MTT for autism and Pitt Hopkins:  Microbes for the mind | ASU News

Webinar on MTT for autism and Pitt Hopkins:  You can watch a webinar on our latest study and research updates at https://www.youtube.com/watch?v=vawc1tbXNgs

Frequently Asked Questions:  Here is a link to questions about MTT for autism and Pitt Hopkins.   https://docs.google.com/document/d/e/2PACX-1vTFNwaNfX7vd1S9hiq6iVkVG-NxWnGhGVxD-dsahd84JcGYMGQLwSL61VqzZvCmV45o8eQGbIQ1Jc_I/pub

Gut-Brain Axis Therapeutics Inc.  Our research team has formed this new company to raise funds from investors to support further research on MTT for autism and Pitt Hopkins so that we can achieve FDA approval and provide it to millions of people worldwide.  You can learn more at https://www.gutbrainaxistherapeutics.com

Publications:

• Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study - PubMed (nih.gov)
• Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota - PubMed (nih.gov)

MTT for Pitt Hopkins Syndrome:  We also conducted a small study of MTT for children with Pitt Hopkins Syndrome, a single-gene disorder involving severe autism, severe intellectual disability, and often severe constipation and pain.  That study demonstrated good safety and good improvement in GI symptoms and many Pitt Hopkins symptoms.  We are now in discussions with the FDA about seeking FDA approval of MTT for Pitt Hopkins.

 

Vitamin/Mineral/Micronutrient Supplements

Many children and adults with autism have self-limited diets consisting of only a few foods, and sometimes unhealthy foods, so that they have low consumption of vitamins, minerals, and other essential nutrients.  Also, they have often have an increased need for these nutrients due to increased oxidative stress, mitochondrial dysfunction, and other factors.

We have published several studies demonstrating that a vitamin/mineral/micronutrient supplement can significantly improve nutritional and metabolic status and improve autism-related symptoms.  

The formulation we developed is now available from the non-profit Autism Nutrition Research Center,  https:\\autismNRC.org   Our latest study found that 73% of 161 people rated the benefits as moderate, good, or great.

Publications: 

•  Vitamin/mineral/micronutrient supplement for autism spectrum disorders: a research survey - PubMed (nih.gov)
• Effect of a vitamin/mineral supplement on children and adults with autism - PubMed (nih.gov)
• Nutritional and metabolic status of children with autism vs. neurotypical children, and the association with autism severity - PubMed (nih.gov)

Comprehensive Nutritional Supplementation

We conducted a 12-month study of the combined effect of six different nutritional treatments on children and adults with autism.  The treatments included our vitamin/mineral/micronutrient supplement, fish oil, Epsom salt baths (for sulfate), carnitine (for mitochondrial function), digestive enzymes, and a healthy allergen-free diet.

The treatment group improved much more than the control group, including improvements in IQ (7 point gain vs no change) and increase in developmental age (18 months vs 4 months).

The results of that study were used to create the ANRC Guidelines for comprehensive nutritional support, available from http://www.autismnrc.org

Publications:

• Comprehensive Nutritional and Dietary Intervention for Autism Spectrum Disorder-A Randomized, Controlled 12-Month Trial - PubMed (nih.gov)

Autism Diagnostic Medical Tests

We have conducted several studies to better understand the biochemical differences in children and adults with autism, so that we can better diagnose people with autism, and use those biochemical measurements to guide treatment.  Our pilot studies suggest that our tests are about 95% accurate in diagnosing children with autism vs. typically-developing children, and we are now working on improving and validating the tests so that they can eventually be made available for the general population.

Publications:

• Multivariate Analysis of Metabolomic and Nutritional Profiles among Children with Autism Spectrum Disorder - PubMed (nih.gov)

Seizures

Seizures are a serious, and potentially life-threatening, problem which affects about 25% of people with autism by adulthood.  Seizure medications can help some people, but often have significant adverse effects.  Therefore, we conducted two national surveys to determine the best seizure treatments for people with autism, including both standard seizure medications and non-traditional interventions.

Publications:

• Traditional and non-traditional treatments for autism spectrum disorder with seizures: an on-line survey - PubMed (nih.gov)
• Rating of the Effectiveness of 26 Psychiatric and Seizure Medications for Autism Spectrum Disorder: Results of a National Survey - PubMed (nih.gov)

Autism Treatment Rater App – for smart phones

We created a free “Autism Treatment Rater” app (available on iPhones)  which provides ratings on over 150 medications, supplements, diets, and therapies for autism, based on a national research survey of over 1200 families.  The app displays ratings of individual treatments, and allows you to search by symptom to find the top-rated treatments for each symptom

Publications

• Rating of the Effectiveness of 26 Psychiatric and Seizure Medications for Autism Spectrum Disorder: Results of a National Survey - PubMed (nih.gov)
• Ratings of the Effectiveness of Nutraceuticals for Autism Spectrum Disorders: Results of a National Survey - PubMed (nih.gov)

Employment Advice for Adults with Autism

We conducted a statewide employment survey about the challenges adults with autism had with finding and keeping a job, and developed recommendations to help.

Publication:

• Survey of vocational experiences of adults with Autism Spectrum Disorders, and recommendations on improving their employment - IOS Press

Pregnancy Research

Optimal Prenatal Vitamin/Mineral Supplement

During pregnancy, the levels of most vitamins and many minerals decreases significantly, and low levels are associated with many pregnancy complications and infant health problems including autism.  We conducted a major literature review of over 350 published studies to determine the optimal level of each vitamin and each mineral in prenatal supplements for reducing the rate of pregnancy complications and infant health problems.

Those recommendations are now available in our free "Prenatal Rater" (available on iPhones and Android).  The app includes a rating of over 180 prenatal supplements, which vary widely in their content. 

We also used that review to design the first prenatal vitamin/mineral supplement that is tailored for each trimester, which is important because nutritional needs change and generally increase as pregnancy progresses.  For example, approximately 28% of women develop iron deficiency by their third trimester. 

Publications:

• Evidence based recommendations for an optimal prenatal supplement for women in the US: vitamins and related nutrients - PubMed (nih.gov)
• Evidence-Based Recommendations for an Optimal Prenatal Supplement for Women in the U.S., Part Two: Minerals - PubMed (nih.gov)

Neurological Health Foundation (NHF) - www.neurologicalhealth.org

Dr. Adams is the co-founder of the non-profit NHF, which is dedicated to helping women have healthy pregnancies and healthy children.  Currently, about 50% of pregnancies encounter serious complications, including miscarriage (15-20%), preterm birth (10%), iron deficiency anemia (28%), and other problems.  

Dr. Adams chairs the Scientific Advisory Board of NHF, which wrote the Healthy Child Guide, which is a set of recommendations to help women have safer pregnancies and healthy babies.  It can be downloaded from www.neurologicalhealth.org

Dr. Adams also co-organizes the NHF Healthy Pregnancy Summit, which is a set of 30+ interviews with pregnancy experts on many different topics, from preconception planning to birth.  It is available for free at https:\\healthypregnancysummit.com