Probiotics for Quality of Life in Autism Spectrum Disorders

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Autism Spectrum Disorders, Anxiety

In brief

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

Key facts

Study ID

NCT02903030

Run by

Ohio State University

People needed

13

Starts

2016-08-01

Expected to finish

2017-12-01

Last updated by the study team

2020-02-05

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• have DSM-5 ASD on clinical evaluation by a doctoral-level diagnostician, confirmed by Autism Diagnostic Interview-Revised or Autism Diagnostic Observation Schedule;
• be between 3 and 12 years old;
• have >2 mo. abdominal pain, constipation, diarrhea, and/or vomiting, with an item-mean score >2 on at least one scale of the GI module of the PedsQL scale;
• have clinical anxiety symptoms with an item mean of >1.0 (0-3 scale) on the new Autism Anxiety Scale.
• Participants will be recruited from minority, poor, inner city, or rural populations.

You may not qualify if…

• Antibiotics in 2 months prior to enrolling;
• Prior bowel surgery;
• Chronic serious medical condition (e.g., diabetes);
• Weight or height < 3rd %ile for age;
• Chronic anti-inflammatory use within 2 months prior to enrolling;
• History of inflammatory bowel disease, Celiac disease, or eosinophilic disorders (e.g., eosinophilic esophagitis);
• Already taking probiotics within the previous 6 months.

Where it is running

• Ohio State University Wexner Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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