NCT06614166

Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Solarea Bio, Inc · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Product Persistence in GI Tract
• Kinetics
• Rheumatoid Arthritis (RA)
• Bone Density

Interventions

Type	Name	Description
OTHER	SBD111 Probiotic Medical Food	Medical food comprised of probiotics and prebiotic fibers
OTHER	SBD121 Probiotic Medical Food	Probiotic medical food comprised of three lactic acid bacteria and one bacillus

Timeline

• Start date: 2024-06-14
• Primary completion: 2025-05-23
• Completion: 2025-06-28
• First posted: 2024-09-26
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States