Clinical Trial

MTT for Children With ASD Who Have Gastrointestinal Disorders

Active, Not Recruiting Phase 2
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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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-11-27; most recent amendment 2025-04-23.
Status change: Recruiting → Active, Not Recruiting 2023-01-06
Trial Details
NCT Number NCT04182633
Lead Sponsor Arizona State University
Collaborators: University of Minnesota
Conditions Autism Spectrum Disorder, Gastro-Intestinal Disorder, Constipation, Diarrhea
Enrollment 50 participants
Start Date 2019-11-15
Primary Completion 2025-02-28 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-04-25