Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults

Summary

The purpose of this study is to determine whether a modified formulation and daily intake schedule of SBD111 results in similar levels of probiotic microbes in the gut compared with the currently used formulation. SBD111 is a food made of probiotic microbes (bacteria and yeast) and prebiotic dietary fibers (a form of fiber obtained from diet). SBD111 is a medical food used for the dietary management of postmenopausal bone loss.SBD111 was previously found to be safe and well tolerated in a human clinical safety study and a clinical efficacy study. Study participation will include a screening virtual visit, periodic remote questionnaires and check-in calls, and three at-home stool swab sample collections. Eligible participants will be assigned to one of two SBD111 study groups evaluating different formulations and dosing schedules. Each day for a 28-day period, they will take (i) two capsules once daily or (ii) two capsules twice daily (morning and evening), depending on the study group assigned. Investigators will collect demographic information and will ask questions related to dietary intake, bowel habits, and health history. Upon enrollment into the study, participants will receive six at-home stool sample collection kits, two each for baseline, Week 1, and Week 4 analysis. Samples will be collected at home and mailed to a Sōlaria Biō for analysis of the bacterial community that lives in the intestine (the gut microbiome). During the study, participants will also be asked to complete brief questionnaires related to gastrointestinal symptoms, cognitive function, well-being, and sleep. On days 7 and 28 of the study, they will be asked to complete a brief adherence questionnaire and discuss any adverse (negative) events. All participants will receive compensation in the form of gift cards for completing study procedures and returning stool samples. Participants will receive a $50.00 gift card after completing the Week 1 study procedures and after receipt of the mailed baseline and Day 7 stool swab samples. Participants will receive a $150.00 gift card after completing the Week 4 study procedures and after receipt of the mailed Week 4 stool swab sample.

Timeline

Start

2026-04

Primary completion

2027-01

Completion

2027-02

Publications

• Background Miller KJ, Wolff IM, Montes de Oca Valeriano LA, Soto-Giron MJ, Jangi S, Schott EM, Charbonneau MR, Ballok AE, Toledo GV. Targeted detection of microbes in synbiotic medical foods SBD111 and SBD121 to evaluate gut persistence: a randomised, open label trial. Benef Microbes. 2026 Feb 9:1-13. doi: 10.1163/18762891-bja00109. Online ahead of print.
• Background Green RS, Roy T, Morales DD, Morrow C, Neilson R, Schott EM, Charbonneau MR, Ballok AE, Motyl KJ, Toledo GV. A synbiotic medical food improves gut barrier function, reduces immune responses, and inhibits osteoclast activity in models of postmenopausal bone loss aligned with clinical outcomes. J Funct Foods. 2025 Dec;135:107114. doi: 10.1016/j.jff.2025.107114. Epub 2025 Nov 28.
• Background Sahni S, Schott EM, Carroll D, Soto-Giron MJ, Corbett S, Toledo GV, Kiel DP. Randomized clinical trial to test the safety and tolerability of SBD111, an optimized synbiotic medical food combination designed for the dietary management of the metabolic processes underlying osteopenia and osteoporosis. J Microbiol Exp. 2023;11(1):1-11. doi: 10.15406/jmen.2023.11.00379. Epub 2023 Jan 25.
• Background Easson DD Jr, Murphy VA, Ballok AE, Soto-Giron MJ, Schott EM, Rodricks J, Toledo GV. Food safety assessment and toxicity study of the synbiotic consortium SBD111. Food Chem Toxicol. 2022 Oct;168:113329. doi: 10.1016/j.fct.2022.113329. Epub 2022 Aug 7.
• Background Schott EM, Charbonneau MR, Kiel DP, Bukata S, Zuscik MJ, Rosen C, Ballok A, Toledo GV, Steels E, Huntress H, Rao A, Ebelt P, Travison TG, Soto-Giron MJ, Wolff I, Easson DD Jr, Engelke K, Vitetta L. A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy of the synbiotic medical food, SBD111, for the clinical dietary management of bone loss in menopausal women. Osteoporos Int. 2025 Oct;36(10):2019-2030. doi: 10.1007/s00198-025-07650-7. Epub 2025 Aug 15.

Drugs

Indications