Combination Probiotic: BB-12 With LGG (Different Doses) in Treating Children With Autism Spectrum Disorder
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
This protocol is a blinded randomized controlled study of the effects of BB-12 with LGG at
different doses in 70 healthy children with autism spectrum disorders at lower and higher
doses over an 56-day period and a 28- day observation period. The study is being conducted in
order to assess safety and tolerability of the probiotic (BB-12 with LGG) at 2 different
doses of BB-12 with LGG. Identifying effects on behaviors in healthy children with ASD using
SRS-2 and ABC, GI symptoms using GI symptom severity index, and relevant biomarkers of
inflammation, microbiota, and metabolites. Primary testing and procedures will be conducted
at the University of Texas Health Science Center at Houston and Memorial Hermann.
Biomarker identification includes Integrative analysis of plasma metabolome and stool
microbiota will be conducted with the collaboration of Dr. Ruth Ann Luna and Dr. Jim
Versalovic at Alkek Center for Metagenomics and Microbiome Research, Department of Molecular
Virology & Microbiology of Baylor College of Medicine.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institutes of Health (NIH) Texas Higher Education Coordinating Board