NCT02504554|CompletedPhase 1/2ResultsDMC
Beneficial Bacteria Treatment for Autism
BBT
Treating Gastrointestinal Problems in Children With Autism Using Beneficial Bacteria Treatment (BBT)
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Sponsor study identifier
interventional
18
0 countries
N/A
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
March 30, 2015
Actual (reported)July 22, 2015
Actual (reported)April 2016
Actual (reported)April 2016
Actual (reported)December 18, 2019
Actual (reported)Gastrointestinal Symptom Responsiveness Scale (GSRS)
The GSRS is a measure of gastrointestinal symptoms. It includes 15 questions, rated on a Likert scale of 1-7, from no symptoms to severe symptoms, respectively (i.e., higher is worse). We report an average score for all 15 questions, so the possible range for the average score is also 1-7.
Baseline and 10 weeks (end of treatment)
Parent Global Impressions-Revised (PGI-R)
Baseline and 10 weeks (end of treatment)
Blood Safety Markers (Assessment of Blood Chemistry Panel and Complete Blood Count)
Baseline and 10 weeks (end of treatment)
Childhood Autism Rating Scale (CARS)
Baseline and 10 weeks (end of treatment)
Social Responsiveness Scale (SRS)
Baseline and 10 weeks (end of treatment)
Short Sensory Profile
baseline and 10 weeks
This group will receive all treatments orally. The treatments include a combination of Vancomycin, MoviPrep, Prilosec, and human fecal material; processed, frozen.
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.
Kang DW, Adams JB, Vargason T, Santiago M, Hahn J, Krajmalnik-Brown R. Distinct Fecal and Plasma Metabolites in Children with Autism Spectrum Disorders and Their Modulation after Microbiota Transfer Therapy. mSphere. 2020 Oct 21;5(5):e00314-20. doi: 10.1128/mSphere.00314-20.
Kang DW, Adams JB, Coleman DM, Pollard EL, Maldonado J, McDonough-Means S, Caporaso JG, Krajmalnik-Brown R. Long-term benefit of Microbiota Transfer Therapy on autism symptoms and gut microbiota. Sci Rep. 2019 Apr 9;9(1):5821. doi: 10.1038/s41598-019-42183-0.
Small study, open-label design, but able to demonstrate safety and possible efficacy. Dosage and duration not optimized, so adjustments in dosage and/or duration may improve results. Therapy involved 4 medications; not clear if all needed.
James B Adams, PhD
Arizona State University
18 participants (actual enrollment reported by the registry).
First Submitted
March 30, 2015
First Posted
July 22, 2015
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
human fecal material; processed, frozen, administered orally
human fecal material; processed, frozen; administered orally and rectally
Contact the study team to confirm eligibility.
Kang DW, Adams JB, Gregory AC, Borody T, Chittick L, Fasano A, Khoruts A, Geis E, Maldonado J, McDonough-Means S, Pollard EL, Roux S, Sadowsky MJ, Lipson KS, Sullivan MB, Caporaso JG, Krajmalnik-Brown R. Microbiota Transfer Therapy alters gut ecosystem and improves gastrointestinal and autism symptoms: an open-label study. Microbiome. 2017 Jan 23;5(1):10. doi: 10.1186/s40168-016-0225-7.
Primary Completion
April 2016
Actual (reported)Study Completion
April 2016
Actual (reported)Last Updated
September 12, 2025
Results First Posted
December 18, 2019
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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