SBD111 Probiotic Dosing Frequency Trial in Healthy Adults NCT07538167
ClinicalTrials.gov Studies
Summary
NIH has registered a new clinical trial (NCT07538167) sponsored by Sōlaria Biō to evaluate whether a modified formulation and dosing schedule of SBD111 results in similar gut probiotic levels compared with the current formulation. SBD111 is a probiotic medical food used for dietary management of postmenopausal bone loss. Participants will be assigned to once-daily or twice-daily capsule dosing over 28 days, with stool sample collection at baseline, Week 1, and Week 4 for microbiome analysis.
“Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults”
What changed
NIH has registered a new clinical trial on ClinicalTrials.gov documenting a study sponsored by Sōlaria Biō to evaluate the gut microbiome response to different formulations and dosing schedules of SBD111, a probiotic medical food. The randomized, two-arm study will assign healthy adults to either (i) two capsules once daily or (ii) two capsules twice daily for 28 days, with stool sample analysis at baseline, Week 1, and Week 4.
For compliance readers, this registry entry is informational only and does not create any compliance obligations. Firms developing probiotic medical foods or dietary supplements for bone health indications may wish to monitor this study for data on dosing optimization and gut microbiome effects, but no regulatory action or reporting requirement is triggered by this registration.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Food Trial Evaluating Fecal Abundance of SBD111 With Once-Daily Versus Twice-Daily Administration in Healthy Adults
N/A NCT07538167 Kind: NA Apr 20, 2026
Abstract
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 ask...
Conditions: Osteopenia, Osteoporosis, Menopause Related Conditions, Probiotic Intervention, Synbiotics
Interventions: SBD111(current formulation), SBD111 (new formulation)
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