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NCT03408886 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Autism Spectrum Disorder and Gastrointestinal Disorder, sponsored by Arizona State University.

Active
Registry status
Phase 2
Development phase
55
Enrollment target
1
Study location

NCT03408886 is a Phase 2 study of Autism Spectrum Disorder and Gastrointestinal Disorder that is active but no longer recruiting, run by Arizona State University. The registered enrollment target is 55 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03408886, a Phase 2 study of Autism Spectrum Disorder and Gastrointestinal Disorder, is active but no longer recruiting, sponsored by Arizona State University.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
55 participants
Enrollment target
1
Study location

Study Summary

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.

Interventions

  • DRUG Vancomycin
  • DRUG MoviPrep
  • BIOLOGICAL Full Spectrum Microbiota

Study Locations (1)

Arizona

  • Arizona State University - Tempe

Trial Details

FieldValue
Enrollment Target 55 participants
Start Date 2018-01-04
Est. Completion 2024-12-15
Phase Phase 2

Sponsor

Arizona State University

187 total trials

What the Registry Record Tells You About NCT03408886

The ClinicalTrials.gov registry entry for NCT03408886 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (59% lower). The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 3 interventions - of which Vancomycin is the first listed.

NCT03408886 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.

Frequently Asked Questions

What is clinical trial NCT03408886 about?

NCT03408886 is a clinical study titled "Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders". 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 gastroi...

What is the current status of trial NCT03408886?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2018-01-04. Estimated completion is 2024-12-15.

What conditions does trial NCT03408886 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Gastrointestinal Disorder.

What interventions are being tested in trial NCT03408886?

The interventions under investigation include: Vancomycin (DRUG), MoviPrep (DRUG), Full Spectrum Microbiota (BIOLOGICAL).

Who is sponsoring clinical trial NCT03408886?

This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03408886 being conducted?

This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.