Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04182633 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

MTT for Children With ASD Who Have Gastrointestinal Disorders

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Aug 30, 2023 to Feb 28, 2025
    • Study completion date: Dec 30, 2024 to Dec 30, 2025
    • Collaborators: 2 to 1
    v7
  2. Primary completion date changed from estimate of Aug 1, 2023 to Aug 30, 2023v6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 70 to confirmed 50
    • Primary completion date: Feb 28, 2023 to Aug 1, 2023
    • Site details revised
    v5
  4. Primary completion date: Jun 30, 2022 to Feb 28, 2023
    • Study completion date: Jun 30, 2024 to Dec 30, 2024
    v4
  5. Primary completion date: Jun 30, 2021 to Jun 30, 2022
    • Study completion date: Jun 30, 2023 to Jun 30, 2024
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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).
Trial Details
NCT Number NCT04182633
Lead Sponsor Arizona State University
Collaborators: University of Minnesota
Conditions
(from sponsor)		 Autism Spectrum Disorder, Gastro-Intestinal Disorder, Constipation, Diarrhea
Related terms Autism Spectrum Disorder, Autistic Disorder, Constipation, Diarrhea, Digestive System Diseases
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov