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

Starting soon · Not applicable

Conditions studied: Osteopenia, Osteoporosis, Menopause Related Conditions, Probiotic Intervention, Synbiotics

In brief

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 facts

Study ID: NCT07538167
Run by: Solarea Bio, Inc
People needed: 80
Starts: 2026-04-01
Expected to finish: 2027-02-01
Last updated by the study team: 2026-04-20

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days. If participant is willing to stop taking probiotic or prebiotic supplement for 30-days, they can be re-screened for eligibility and enrollment after consent.
Unwilling to avoid probiotics/prebiotics supplements for the duration of the study.
Known or suspected allergies to probiotics, maltodextrin, or berries.
Received oral or parenteral antibiotics within 30 days of enrollment or prescribed antibiotics on the day of enrollment.
Major surgery on the intestines or endoscopy within last 3 months.
History of drug and/or alcohol abuse at the time of enrollment.
Presence of any of the following based on participant reported health history:
Clinically significant systems abnormalities based on screening questionnaire.
Indwelling catheter or feeding tube.
Febrile illness (oral temperature >37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline (first administration of study article).
Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, or inflammatory bowel disease.
History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease.
Underlying structural heart disease or previous history of endocarditis or valve replacement.
Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy.
History of Celiac disease.
History of cancer.
a. Excluding non-melanoma skin cancers or cancer more than 10 years ago.
History of autoimmune disease and taking any immunosuppressant drugs.
Active tuberculosis.
Pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test within 24 hours of first administration of DMA.
Participants may be excluded if, in the investigator's opinion, there is evidence of cognitive impairment or dementia which is sufficient to interfere with informed consent or adherence to the study protocol. Four questions will be asked during the informed consent process to confirm participant's understanding and ability to comply. (See section 8.3)
Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.
Bowel movement frequency less than one per 36-hour period.
If the subject has been in a recent experimental trial, these must have been completed not less than 30 days prior to this study.

Full record on ClinicalTrials.gov

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