drugset / Trial / NCT04132427

MTT for Children With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders

NCT04132427

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Pitt Hopkins Syndrome (PTHS) and gastrointestinal problems similar to Irritable Bowel Syndrome (IBS). 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
2019-09-30
Primary completion
2022-03-17
Completion
2022-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Fecal Microbiota Other / unclassified Oral
Subject Vancomycin Other / unclassified Oral
Background Magnesium Citrate Unknown Oral

Indications