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

Sponsor
Solarea Bio, Inc
Study ID
NCT07538167
Status
Not Yet Recruiting

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Conditions

  • Menopause Related Conditions
  • Osteopenia
  • Osteoporosis
  • Probiotic Intervention
  • Synbiotics

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SBD111(current formulation) — COMBINATION_PRODUCT
    SBD111 (current formulation) is a combination of probiotic bacteria and yeast as well as prebiotic fibers taken twice daily
  • SBD111 (new formulation) — COMBINATION_PRODUCT
    SBD111 (new formulation) is a combination of probiotic bacteria and yeast as well as prebiotic fibers taken once daily

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: SBD111 (current formulation)
    SBD111 (Bondia), is a commercial medical food for dietary management of postmenopausal bone loss. This product is taken twice daily.
  • Experimental: SBD111 (New formulation)
    SBD111 (New formulation) contains the same daily amount probiotic microbes but is formulated to be taken once daily.

Primary Outcome Measure

Composite fecal abundance of SBD111 microbial strains measured by strain-specific qPCR [ Time Frame: From enrollment out to 28 days of consuming the product ]

Central Contacts

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