Overview

This trial is active, not recruiting.

Conditions gastrointestinal problems, autism spectrum disorders
Treatments oral vancomycin, moviprep, prilosec, human fecal material; processed, frozen administered orally, human fecal material; processed, frozen; administered orally and rectally
Phase phase 1/phase 2
Sponsor Arizona State University
Collaborator Northern Arizona University
Start date July 2014
End date April 2016
Trial size 20 participants
Trial identifier NCT02504554, STUDY00001053

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
oral vancomycin
an antibiotic
moviprep
a bowel cleanse
prilosec
a stomach acid suppressan
human fecal material; processed, frozen administered orally
human fecal material; processed, frozen, administered orally
(Experimental)
This group will receive some treatments rectally and some orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
oral vancomycin
an antibiotic
moviprep
a bowel cleanse
prilosec
a stomach acid suppressan
human fecal material; processed, frozen; administered orally and rectally
human fecal material; processed, frozen; administered orally and rectally

Primary Outcomes

Measure
Gastrointestinal Symptom Responsiveness Scale
time frame: 10 weeks

Secondary Outcomes

Measure
Parent Global Impressions-Revised
time frame: 10 weeks
blood safety markers (assessment of blood chemistry panel and complete blood count)
time frame: 10 weeks
Childhood Autism Rating Scale
time frame: 10 weeks
Social Responsiveness Scale
time frame: 10 weeks
Short Sensory Profile
time frame: 10 weeks
Vineland Adaptive Behavior Scale
time frame: 18 weeks
stool diary
time frame: 10 weeks

Eligibility Criteria

Male or female participants from 7 years up to 17 years old.

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

Additional Information

Official title Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)
Principal investigator James B Adams, PhD
Description This is an open-label clinical trial to evaluate the safety, tolerability, and feasibility of a combination therapy to treat gastrointestinal problems in children with autism spectrum disorders. It involves a combination therapy including beneficial bacteria.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Arizona State University.