Overview

Beneficial Bacteria Treatment for Autism

Status:
Completed

Trial end date:
2016-04-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Arizona State University

Collaborators:

Northern Arizona University
University of Arizona
University of Minnesota
University of Minnesota - Clinical and Translational Science Institute

Treatments:

Omeprazole
Vancomycin

Criteria

Inclusion Criteria:

1. Children ages 7-17 years

2. Diagnosis of autism per Autism Diagnostic Interview-Revised (ADI-R)

3. Moderate or Severe GI problems ( on the GSRS, a single score of 4 (severe) on any
item, or a score of 3 (moderate) on two items, or a score of 2 (mild) or more on any 4
items

4. No changes in medications, supplements, diet, therapies, or education in last 3
months, and no intention to change them during clinical trial

5. General good physical health aside from gastrointestinal problems

6. Cognitive Ability to Provide Informed Assent

Exclusion Criteria:

1. Antibiotics in last 6 months

2. Probiotics in last 3 months

3. Single-gene disorder (Fragile X, etc.)

4. Major brain malformation

5. Tube feeding

6. Severe gastrointestinal problems that require immediate treatment (life-threatening)

7. Ulcerative Colitis, Crohn's Disease, diagnosed Celiac Disease, Eosinophilic
Gastroenteritis, or similar conditions

8. Severely underweight/malnourished

9. Recent or scheduled surgeries

10. Current participation in other clinical trials