drugset / Trial / NCT04182633

MTT for Children With ASD Who Have Gastrointestinal Disorders

NCT04182633

Phase 2 Active not recruiting 50 enrolled Arizona State University University of Minnesota · collab
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2019-11-15
Primary completion
2025-02-28
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Vancomycin Other / unclassified Oral
Subject intestinal microbiota Unknown Oral
Background polyethylene glycol Other / unclassified