NCT03408886|Active Not RecruitingPhase 2DMCFDA Drug
Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders
MTT-ASD
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Department of Defense
interventional
55
1 country
1
Study Start
January 4, 2018
Actual (reported)Primary Completion
April 15, 2022
Actual (reported)Study Completion
December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a clinical trial of Microbiota Transplant Therapy (MTT) for adults with autism spectrum disorders (ASD) who have gastrointestinal problems. Previous research has shown that individuals with ASD have a low diversity of gut bacteria, and low diversity is generally associated with poor gastrointestinal (GI) health. We previously found that MTT therapy for children with ASD and GI symptoms was helpful in reducing their GI symptoms, reducing their ASD symptoms, and increasing their diversity of gut bacteria. This clinical trial will investigate the hypothesis that MTT therapy will be helpful for adults with ASD who have GI symptoms.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 4, 2018
Actual (reported)January 8, 2018
Actual (reported)January 24, 2018
Actual (reported)April 15, 2022
Actual (reported)December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in Childhood Autism Rating Scale (CARS) from baseline to 10 weeks
An evaluation by a trained evaluator of autism symptoms. The range is 15-60, and scores in the range of 27-30 or higher are indicative of autism.
baseline; month 2.5, 4.5, 10.5, 16.5, 22.5
Change in Daily Stool Log (DSL) from baseline to 10 weeks
baseline for 2 weeks; daily for 18 weeks, and 2 weeks at month 10, 16, 22
Change in Social Responsiveness Scale - 2 from baseline to 10 weeks of treatment
baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; months 10.5, 16.5, 22.5
Change in Aberrant Behavior Checklist from baseline to 10 weeks
baseline; month 2.5, 4.5, 10.5, 16.5, 22.5
Change in Gastrointestinal Stool and Symptom Questionnaire for Autism, from baseline to 10 weeks
baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18; month 10.5, 16.5, 22.5
Change in Microbiome composition from baseline to 10 weeks
baseline; month 1, 2.5, 3.5, 4.5, 10.5, 16.5, 22.5
Change in the Vineland Adaptive Behavior Scale - II, from baseline to 10 weeks
baseline; month 2.5, 4.5, 22.5
Group A receives treatment in Part 1 and Part 2
Group B receives no treatment in Part 1, but does receive treatment in Part 2
Oral vancomycin is administered to reduce pathogenic bacteria.
MoviPrep is given at the end of vancomycin therapy to remove the vancomycin and remaining bacteria prior to administering Full-Spectrum Microbiota
Arizona State University
Tempe, Arizona, 85287, United States
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.
James B Adams, PhD
Arizona State University
55 participants (actual enrollment reported by the registry).
First Submitted
January 8, 2018
First Posted
January 24, 2018
A Study to Investigate the Efficacy, Safety, and Tolerability of JNJ-42165279 in Adolescent and Adult Participants With Autism Spectrum Disorder
Gut bacteria from healthy human donors are administered orally in a pill form
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
January 4, 2018
Actual (reported)Primary Completion
April 15, 2022
Actual (reported)Study Completion
December 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 9, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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