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Beneficial Bacteria Treatment for Autism

NCT02504554 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-09-12

Study results available
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Summary

This is an open-label clinical trial to investigate a combination therapy for treating gastrointestinal problems in children with autism spectrum disorders.

The combination therapy includes beneficial bacteria.

Conditions

  • Gastrointestinal Problems
  • Autism Spectrum Disorders

Interventions

DRUG

oral Vancomycin

an antibiotic

DRUG

MoviPrep

a bowel cleanse

DRUG

Prilosec

a stomach acid suppressan

BIOLOGICAL

human fecal material; processed, frozen administered orally

human fecal material; processed, frozen, administered orally

BIOLOGICAL

human fecal material; processed, frozen; administered orally and rectally

human fecal material; processed, frozen; administered orally and rectally

Sponsors & Collaborators

  • Northern Arizona University

    collaborator OTHER

  • University of Arizona

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Arizona State University

    lead OTHER

Principal Investigators

  • James B Adams, PhD · Arizona State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-04-30
Completion
2016-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02504554 on ClinicalTrials.gov