NCT03408886Active, not recruitingPhase 2
Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders
Source: ClinicalTrials.gov · Last updated 9 Jan 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 8 Jan 2018
- Start date
- 4 Jan 2018
- Primary completion date
- 15 Apr 2022
- Lead sponsor
- Arizona State University
- Diseases
- Autism
- NCT number
- NCT03408886
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 55
- From 4 Jan 2018 to the primary completion date, 15 Apr 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Probiotics in last 2 months, or fecal transplant in last 12 months
Other illness
- Single-gene disorder (Fragile X, etc.)
- Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic Gastroenteritis, or similar conditions
- Allergy or intolerance to vancomycin or MoviPrep
Lab values
- Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential.
- \-
Other
- Antibiotics in last 3 months
- Major brain malformation
- Tube feeding
- Severe gastrointestinal problems that require immediate treatment (life-threatening)
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arizona State University Coordinator of this site? Confirm its status | Tempe | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.