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NCT04182633 · ClinicalTrials.gov registry record · Phase 2
MTT for Children With ASD Who Have Gastrointestinal Disorders
A Phase 2 study of Autism Spectrum Disorder and Constipation, sponsored by Arizona State University.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04182633: Active Phase 2 study of Autism Spectrum Disorder and Constipation, sponsored by Arizona State University.
NCT04182633 is a Phase 2 study of Autism Spectrum Disorder and Constipation that is active but no longer recruiting, run by Arizona State University. The registered enrollment target is 50 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04182633, a Phase 2 study of Autism Spectrum Disorder and Constipation, is active but no longer recruiting, sponsored by Arizona State University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating children with Autism Spectrum Disorder (ASD) and gastrointestinal problems (primarily constipation and/or diarrhea). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by a bowel cleanse, followed by 12 weeks of Fecal Microbiota (FM).
Primary Outcome
An evaluation by a trained evaluator of autism symptoms. The range is 15-60, and scores in the range of 27-30 or higher are indicative of autism.
Conditions Studied
Interventions
- COMBINATION_PRODUCT vancomycin, Miralax, intestinal microbiota
- COMBINATION_PRODUCT placebo vancomycin, Miralax, placebo intestinal microbiota
Study Locations (1)
Arizona
- Arizona State University - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2025-12-30 |
| Phase | Phase 2 |
What the registry record for NCT04182633 still lists
NCT04182633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (63% lower).
The record links to 4 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which vancomycin, Miralax, intestinal microbiota is the first listed.
NCT04182633 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT04182633 about?
NCT04182633 is a clinical study titled "MTT for Children With ASD Who Have Gastrointestinal Disorders". The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating children with Autism Spectrum Disorder (ASD) and gastrointestinal problems (primarily constipation and/or diarrhea). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bact...
What is the current status of trial NCT04182633?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2019-11-15. Estimated completion is 2025-12-30.
What conditions does trial NCT04182633 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Constipation, Diarrhea, Gastro-Intestinal Disorder.
What interventions are being tested in trial NCT04182633?
The interventions under investigation include: vancomycin, Miralax, intestinal microbiota (COMBINATION_PRODUCT), placebo vancomycin, Miralax, placebo intestinal microbiota (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04182633?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04182633 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04182633's enrollment target sits among peer trials
50 141st of 224 higher than 79 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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