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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04182633
The ClinicalTrials.gov registry entry for NCT04182633 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (63% lower). The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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