Probiotics for Quality of Life in Autism Spectrum Disorders

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Collaborators: Autism Speaks; Autism Treatment Network
• Treatments: Silicon

Criteria

Inclusion Criteria:

1. have DSM-5 ASD on clinical evaluation by a doctoral-level diagnostician, confirmed by Autism Diagnostic Interview-Revised or Autism Diagnostic Observation Schedule;

2. be between 3 and 12 years old;

3. 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;

4. 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.

Exclusion Criteria:

1. Antibiotics in 2 months prior to enrolling;

2. Prior bowel surgery;

3. Chronic serious medical condition (e.g., diabetes);

4. Weight or height < 3rd %ile for age;

5. Chronic anti-inflammatory use within 2 months prior to enrolling;

6. History of inflammatory bowel disease, Celiac disease, or eosinophilic disorders (e.g., eosinophilic esophagitis);

7. Already taking probiotics within the previous 6 months.