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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
BB-12 with LGG - Higher Dose (10 billion CFUs)
Maltodextrin
BB-12 with LGG - Lower Dose (1 billion CFUs)
UTHealth
Houston, Texas, United States
Safety as Indicated by Number of Participants With Invasive Infection Resulting From the Administration of Probiotic
Infection will be determined by clinical observations and temperature measurements made during the study period, as well as complete metabolic panel, complete blood count, and C-reactive protein (CRP) blood testing.
Time frame: from baseline to 56 days
Number of Participants With Clinical Tolerance of the Probiotic
Tolerance will be determined by assessment of symptoms, which will be monitored at clinical research center visits, as well as ability to remain on the treatment.
Time frame: from baseline to 56 days
Safety as Indicated by Number of Participants With Toxicity Resulting From the Administration of Probiotic
Toxicity will be determined by assessment of electrolyte status, renal function \[blood urea nitrogen (BUN) and creatinine (Cr), hepatic toxicity \[transaminases (AST, ALT) and total bilirubin\], and hematologic status \[CBC to measure hemoglobin and absolute neutrophil count\].
Time frame: from baseline to 56 days
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