NCT02504554

Beneficial Bacteria Treatment for Autism

Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Arizona State University · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Gastrointestinal Problems
• Autism Spectrum Disorders

Interventions

Type	Name	Description
DRUG	oral Vancomycin	an antibiotic
DRUG	MoviPrep	a bowel cleanse
DRUG	Prilosec	a stomach acid suppressan
BIOLOGICAL	human fecal material; processed, frozen administered orally	human fecal material; processed, frozen, administered orally
BIOLOGICAL	human fecal material; processed, frozen; administered orally and rectally	human fecal material; processed, frozen; administered orally and rectally

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-07-22
• Last updated: 2025-09-12
• Results posted: 2019-12-18