An interventional study of Bacillus coagulans BRCAS-C3 in Androgen Levels, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate the feasibility, safety, and preliminary effects of a probiotic supplement, Bacillus coagulans strain BRCAS-C3, on androgen levels in adult men and women. Androgens are hormones that are naturally present in both men and women. Abnormally high androgen levels in women may be associated with conditions such as polycystic ovary syndrome (PCOS), acne, and hair loss.
The main questions this study aims to answer are:
Is it feasible for participants to take the probiotic supplement daily for 24 weeks and complete all study visits?
Does probiotic supplementation change blood androgen levels after 24 weeks?
What side effects or medical problems, particularly gastrointestinal symptoms such as bloating, gas, or changes in bowel habits, occur during the study?
This is a single-center, open-label pilot study without a placebo or comparison group. Researchers will compare participants' measurements before and after probiotic supplementation to explore changes in hormone levels and other health indicators.
Participants will:
Take one capsule of the probiotic supplement daily for 24 weeks.
Visit the clinic at the beginning of the study, at 12 weeks, and at 24 weeks for health assessments and blood tests.
Provide blood samples to measure androgen levels and other hormone, metabolic, liver, and inflammation-related markers.
Provide stool samples at the beginning of the study, at 12 weeks, and at 24 weeks to assess the presence of the probiotic strain.
Report side effects and undergo assessments of supplement adherence and study completion.
The findings will help researchers evaluate the feasibility and safety of the intervention and obtain preliminary data to guide the design of future clinical trials.
Hyperandrogenemia refers to abnormally elevated levels of androgens, including testosterone and dihydrotestosterone (DHT). In women, elevated androgen levels may be associated with polycystic ovary syndrome (PCOS), acne, excessive hair growth, androgenic alopecia, ovulatory dysfunction, and metabolic disturbances. Current treatments targeting androgen production or action may have systemic adverse effects and may be unsuitable for some individuals, particularly women of reproductive age. Therefore, alternative or complementary approaches to modulating androgen levels warrant further investigation.
Emerging evidence suggests that the gut microbiota may influence sex hormone metabolism and circulating hormone levels. Certain gut bacteria can metabolize steroid hormones, potentially affecting the host's endocrine function. Probiotic supplementation may therefore represent a potential dietary approach to modulating the gut microbiota and its relationship with androgen metabolism.
Bacillus coagulans strain BRCAS-C3 is a probiotic strain that has demonstrated androgen-lowering effects in preclinical animal studies, including reductions in serum testosterone and DHT. However, its effects in humans have not been adequately established. This pilot study will explore the feasibility, safety, and preliminary effects of BRCAS-C3 supplementation on circulating androgen levels in adult men and women.
This is a single-center, open-label, exploratory pilot study using a pre-post design without a placebo or control group. The planned study population consists of 30 men and 30 women aged 18 to 45 years who meet the protocol-defined eligibility criteria. Participants will receive one capsule of BRCAS-C3 probiotic supplementation daily for 24 weeks.
Clinical assessments and laboratory evaluations will be performed at baseline, week 12, and week 24. Blood samples will be collected to evaluate androgen-related hormones and other hormonal, metabolic, liver, and inflammatory markers. Stool samples will be collected at the same time points to investigate the presence and proportion of the administered probiotic strain. Additional assessments will include anthropometric measurements, menstrual characteristics in female participants, and hair-loss evaluations in participants with androgenic alopecia.
Study feasibility will be assessed through recruitment, adherence to the intervention, and participant retention. Safety will be evaluated by monitoring reported adverse symptoms, particularly gastrointestinal intolerance. Changes in laboratory and clinical measurements from baseline to follow-up will be explored using paired statistical methods appropriate to the distribution of the data.
The findings are intended to provide preliminary information on study feasibility, intervention adherence, safety, and potential changes in androgen levels. These data will inform the design and planning of a future larger randomized controlled trial.
National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive one capsule of Bacillus coagulans strain BRCAS-C3 probiotic supplement daily for 24 weeks. Clinical and laboratory assessments will be conducted at baseline, week 12, and week 24 to evaluate study feasibility, safety, and preliminary changes in androgen levels and other health-related markers. Blood and stool samples will be collected at these time points for laboratory analyses.
Dietary Supplement: Bacillus coagulans BRCAS-C3
Bacillus coagulans strain BRCAS-C3, provided as a powder-filled capsule containing a target viable count of 3 × 10\^10 colony-forming units (CFU) per capsule. Participants will take one capsule orally once daily for 24 consecutive weeks. The product will be stored at room temperature in a cool, dry place, protected from direct sunlight.
Change in Serum Total Testosterone from Baseline to Week 24
Serum total testosterone concentrations will be measured at baseline and week 24. The change will be calculated as the week 24 value minus the baseline value. Blood samples will be collected after an 8-hour fast.
Time frame: Baseline, Week 12 and Week 24
Plan to share: No — Individual participant data will not be shared with other researchers because no data-sharing plan has been established for this pilot study. Study results may be disseminated in scientific publications in aggregate form.
Started Sep 2026 (actual). Primary completion is estimated for Aug 2027, 10 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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