MTT for Children With ASD Who Have Gastrointestinal Disorders

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    70
  • sponsor
    Arizona State University
Updated on 20 February 2022
constipation
antibiotic therapy
antibiotics
diarrhea
gastrointestinal disorder
vancomycin
microbiota
autism
pervasive developmental disorder
oral vancomycin
miralax

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).

Description

For children ages 5-17 years with Autism Spectrum Disorder and gastrointestinal problems, a Phase 2 clinical trial will evaluate the safety, tolerability, and efficacy of MTT. The three parts of this trial are described below.

Part 1: Randomized Trial The trial will begin with a randomized, double-blind, placebo-controlled trial which will include a 2-week treatment with oral vancomycin (Group A) or placebo (Group B), then 1 day of Miralax to cleanse the bowel of vancomycin and bacteria/feces (both groups), followed by oral administration of FM (Group A) or placebo (Group B). An initial high dose of FM (or placebo) for two days will be followed by a lower maintenance dose of FM or placebo for 12 weeks.

Part 2: Extension (Group A) and Treatment (Group B)

  • For Group A there will be 12-week observation period
  • For Group B, there will be treatment similar to that received by the treatment group in Part 1 (partial cross-over, open-label), except that they will not receive vancomycin. So, they will be treated with Miralax followed by an initial high dose of FM for 2 days, and then a maintenance dose of FM for 12 weeks. The purpose of this arm is to determine if vancomycin is necessary or not.

Part 3: Follow-up There will be a follow-up evaluation at 6, 12, and 18 months after treatment ends, to determine long-term safety and efficacy.

Participant duration will be approximately 6.5 months for treatment, and follow-up at 6, 12 and 18 months after treatment ends.

Study duration will be approximately 4 years, including IRB approvals, training staff, recruiting, clinical trial, data analysis, and reporting.

Details
Condition Autism Spectrum Disorder, Gastro-Intestinal Disorder, Constipation, Diarrhea
Treatment vancomycin, Miralax, intestinal microbiota, placebo vancomycin, Miralax, placebo intestinal microbiota
Clinical Study IdentifierNCT04182633
SponsorArizona State University
Last Modified on20 February 2022

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