Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical trial of Microbiota Transplant Therapy (MTT) for adults with autism spectrum disorders (ASD) who have gastrointestinal problems.

Previous research has shown that individuals with ASD have a low diversity of gut bacteria, and low diversity is generally associated with poor gastrointestinal (GI) health. We previously found that MTT therapy for children with ASD and GI symptoms was helpful in reducing their GI symptoms, reducing their ASD symptoms, and increasing their diversity of gut bacteria.

This clinical trial will investigate the hypothesis that MTT therapy will be helpful for adults with ASD who have GI symptoms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arizona State University
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

1. Adult aged 18-60 years

2. Diagnosis of autism per both the Autism Diagnostic Interview - Revised (ADI-R) and the Childhood Autism Rating Scale 2 (CARS-2).

3. GI disorder as defined below that has lasted for at least 3 years.

4. No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during the clinical trial.

5. General good physical health aside from gastrointestinal problems

6. Neurotypical adult observer (such as parent, guardian, or sibling) who observes adult for at least 4 hours/week who can serve as an Evaluator to complete questionnaires on their symptoms with the assistance of the Participant as much as they are able.

7. Ability to swallow pills (without chewing)

Exclusion Criteria:

1. Antibiotics in last 3 months

2. Probiotics in last 2 months, or fecal transplant in last 12 months

3. Single-gene disorder (Fragile X, etc.)

4. Major brain malformation

5. Tube feeding

6. Severe gastrointestinal problems that require immediate treatment (life-threatening)

7. Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions

8. Severely underweight/malnourished

9. Recent or scheduled surgeries

10. Current participation in other clinical trials

11. Females who are pregnant or who are sexually active without effective birth control. We will conduct a urine pregnancy test on all female participants as part of the screening and at each clinical visit.

12. Allergy or intolerance to vancomycin or MoviPrep

13. Clinically significant abnormalities at baseline on two blood safety tests:

Comprehensive Metabolic Panel and Complete Blood Count with Differential.

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