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Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders

Study acronym: MTT-ASD
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of Oct 4, 2022 to Apr 15, 2022
    • Study completion date: Sep 1, 2023 to Dec 15, 2024
    v5
  2. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 84 to confirmed 55
    • Site details revised
    v4
  3. Notable Primary completion date: Oct 4, 2020 to Oct 4, 2022
    • Study completion date: Sep 1, 2021 to Sep 1, 2023
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a clinical trial of Microbiota Transplant Therapy (MTT) for adults with autism spectrum disorders (ASD) who have gastrointestinal problems. Previous research has shown that individuals with ASD have a low diversity of gut bacteria, and low diversity is generally associated with poor gastrointestinal (GI) health. We previously found that MTT therapy for children with ASD and GI symptoms was helpful in reducing their GI symptoms, reducing their ASD symptoms, and increasing their diversity of gut bacteria. This clinical trial will investigate the hypothesis that MTT therapy will be helpful for adults with ASD who have GI symptoms.
Trial Details
NCT Number NCT03408886
Lead Sponsor Arizona State University
Conditions
(from sponsor)
Autism Spectrum Disorder, Gastrointestinal Disorder
Related terms Autism Spectrum Disorder, Gastrointestinal Diseases
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov