This study is a randomized, open-label, trial in healthy volunteers. Trial participants will be given a medical food product (combination of probiotics and prebiotics) called SBD111 or SBD121 for seven days and microbial abundance in feces will be measured during that time and for four weeks following administration.
This DMA persistence food trial provides critical complimentary data to the ongoing efficacy food trials of SBD111 and SBD121 medical foods. While the SBD111 and SBD121 medical food products have been tested in multiple preclinical studies, GLP-Toxicity studies in Rats, and ongoing safety and efficacy trials, no study has yet examined how quickly these DMAs become detectable/active in human stool samples or the rate they clear from human stool following treatment cessation. The data provided by this study could inform the interpretation efficacy trial data with regard to subject adherence. Objectives The primary goal of this study is to evaluate the prevalence and persistence of SBD111 and SBD121 medical foods, two novel combinations of probiotics and prebiotic dietary fibers, over time in stool samples. We will determine the effect of these Defined Microbial Assemblages (DMAs) on fecal microbiota composition and functional potential, as well as the duration of SBD111 and SBD121 product persistence in the gastrointestinal tract. DMAs will be administered for 7 days, and stool samples will be collected during DMA administration and up to 28 days post DMA cessation for microbial DNA extraction. Fecal microbial DNA will be subjected to qPCR and high throughput shotgun sequencing to determine the presence and amount of DMA microbes that are present before, during, and after DMA administration. We will also use the resulting shotgun sequencing data to determine whether any taxonomic shifts or functional changes occur in response to DMA administration and/or cessation. Finally, as an exploratory measure, we will attempt to isolate live DMA microbes from participants' fecal samples using microbiological techniques.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Medical food comprised of probiotics and prebiotic fibers
Probiotic medical food comprised of three lactic acid bacteria and one bacillus
Solarea Bio Inc
Waltham, Massachusetts, United States
Persistence of SBD111 and SBD121 microbes in fecal samples
DNA isolated from fecal swabs will be used to determine the persistence of SBD111 and SBD121 microbes in stool samples up to 28 days following twice-daily oral administration of SBD111 or SBD121 to healthy adults.
Time frame: 5 weeks
Microbial Community Structure Changes
Using metagenomic sequencing, we will assess microbial community structural and functional changes that occur during and up to 28 days following twice-daily oral administration of SBD111 or SBD121 to healthy adults. This will be done via sequence assessment of microbiota taxonomies and functional genes.
Time frame: 5 weeks
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Enrollment
40