Status:
ACTIVE_NOT_RECRUITING
Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders
Lead Sponsor:
Arizona State University
Conditions:
Autism Spectrum Disorder
Gastrointestinal Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 A...
Detailed Description
For adults ages 18-60 years with ASD and gastrointestinal problems, the investigators propose a Phase 2 clinical trial to evaluate the safety and efficacy of MTT. The study will also determine if long...
Eligibility Criteria
Inclusion
- Adult aged 18-60 years
- Diagnosis of autism per both the Autism Diagnostic Interview - Revised (ADI-R) and the Childhood Autism Rating Scale 2 (CARS-2).
- GI disorder as defined below that has lasted for at least 3 years.
- No changes in medications, supplements, diet, therapies, or education in last 3 months, and no intention to change them during the clinical trial.
- General good physical health aside from gastrointestinal problems
- 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.
- Ability to swallow pills (without chewing)
Exclusion
- Antibiotics in last 3 months
- Probiotics in last 2 months, or fecal transplant in last 12 months
- Single-gene disorder (Fragile X, etc.)
- Major brain malformation
- Tube feeding
- Severe gastrointestinal problems that require immediate treatment (life-threatening)
- Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions
- Severely underweight/malnourished
- Recent or scheduled surgeries
- Current participation in other clinical trials
- 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.
- Allergy or intolerance to vancomycin or MoviPrep
- Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential.
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Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03408886
Start Date
January 4 2018
End Date
December 15 2024
Last Update
January 9 2023
Active Locations (1)
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1
Arizona State University
Tempe, Arizona, United States, 85287