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Probiotics for Quality of Life in Autism Spectrum Disorders

NCT02903030 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-02-05

Study results available
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Summary

A randomized pilot trial of a probiotic for quality of life in autism spectrum disorder (ASD), targeting gastrointestinal (GI) symptoms.

Conditions

  • Autism Spectrum Disorders
  • Anxiety

Interventions

DRUG

Maltose (placebo)

Maltose with a trace amount of silicon dioxide

DRUG

Visbiome Extra Strength

It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety

Sponsors & Collaborators

  • Autism Treatment Network

    collaborator NETWORK

  • Autism Speaks

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • Eugene Arnold, MD · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-12-01
Completion
2017-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02903030 on ClinicalTrials.gov