Androgen LevelsNCT07911813
Effects of Probiotic Supplementation on Androgen Levels
A study testing Bacillus coagulans BRCAS-C3 in people with Androgen Levels, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgen Levels
- What is being tested?
- Bacillus coagulans BRCAS-C3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2026to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged between 18-45 y/o.
- For women: Total testosterone > 0.7 ng/mL or free androgen index (FAI) > 6.1. For Men: Total testosterone level within NTUH Department of Laboratory Medicine reference ranges (2.40 - 8.71 ng/mL).
- Willingness to maintain their baseline diet, physical activity levels and skin care routines throughout the 24 weeks study duration.
- Understand the study protocols and provide written informed consent.
- For female participants with childbearing potential: Agreement to use non-hormonal contraception throughout the study.
Who cannot join
- Medication/Interventions: Use of hormonal contraceptives, ovulation induction agents, anti-androgens (e.g., spironolactone, finasteride, flutamide, oral retinoic acid, cyproterone acetate), metformin, GLP-1 receptor agonists, systemic steroids, or traditional Chinese medicine (TCM) formulations derived for endocrine, metabolic, or weight-loss purposes within the past 3 months.
- History of benign prostatic hyperplasia (BPH), prostate cancer, or other urological diseases, with use of GnRH agonists (e.g., leuproreline, goserelin, triptorelin), first-generation anti-androgens (e.g., cyproterone acetate, bicalutamide), or second-generation anti-androgens (e.g., abiraterone, enzalutamide, apalutamide) within the past 6 months.
- Antibiotics/Probiotics Washout: Use of systemic antibiotics, antifungals, or commercial high dose probiotic supplements within the past 4 weeks prior to baseline.
- Gastrointestinal Disorders: History of severe chronic gastrointestinal diseases such as Inflammatory bowel disease, Celiac disease, colon cancer, or major bowel surgery that significantly alter nutrient absorption.
- Endocrine pathologies as androgen-secreting tumor, Cushing syndrome, or untreated thyroid disorders.
- Current pregnancy, lactation, or planning to become pregnant during the trial.
- Known allergy or hypersensitivity to any components of the investigational product, including Bacillus coagulans, plant-based capsule ingredients (such as glycerol or pectin), or antioxidants including vitamin C and vitamin E.
- Subjects who will be evaluated for androgenic alopecia should not use topical or oral minoxidil, oral finasteride, dutasteride, lower level laser therapy within the last 6 months, and should not use hair dyes, chemical perms or major changing of hair styling routine within 4 weeks of baseline and during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, National Taiwan University Hospital
Taipei, Taipei City, 100
Mei-Jou Chen, MD, PHD, +886 972651979, mjchen04@ntu.edu.tw
About this study
Official title: Modulation of Androgen Levels Via Probiotics Supplementation: A Pilot Feasibility Study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Androgen Levels
- Being tested
- Bacillus coagulans BRCAS-C3
- Keywords
- Bacillus coagulans, BRCAS-C3, Probiotics, Androgen Levels, Testosterone, Dihydrotestosterone, Gut Microbiota, Pilot Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus coagulans BRCAS-C3Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| BRCAS-C3 Probiotic Supplementation | Experimental | 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. Receives: Dietary Supplement: Bacillus coagulans BRCAS-C3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start30 Sep 2026
- Primary completion13 Aug 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Androgen LevelsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GeneFerm Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Mei-Jou Chen, Principal investigator, Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei 100, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911813
- Sponsor's protocol ID
- 202607031RIPB
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Yang PK, Chou CH, Chang CH, Chen SU, Ho HN, Chen MJ. Changes in peripheral mitochondrial DNA copy number in metformin-treated women with polycystic ovary syndrome: a longitudinal study. Reprod Biol Endocrinol. 2020 Jul 13;18(1):69. doi: 10.1186/s12958-020-00629-5.
PubMed 32660613Yang PK, Hsu CY, Chen MJ, Lai MY, Li ZR, Chen CH, Chen SU, Ho HN. The Efficacy of 24-Month Metformin for Improving Menses, Hormones, and Metabolic Profiles in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2018 Mar 1;103(3):890-899. doi: 10.1210/jc.2017-01739.
PubMed 29325133Hashemi S, Ramezani Tehrani F, Noroozzadeh M, Azizi F. Normal cut-off values for hyperandrogenaemia in Iranian women of reproductive age. Eur J Obstet Gynecol Reprod Biol. 2014 Jan;172:51-5. doi: 10.1016/j.ejogrb.2013.09.029. Epub 2013 Oct 19.
PubMed 24220143Zhou Z, Ni R, Hong Y, Li Y, Wang Y, Zhao X, Yang D. Defining hyperandrogenaemia according to the free androgen index in Chinese women: a cross-sectional study. Clin Endocrinol (Oxf). 2012 Sep;77(3):446-52. doi: 10.1111/j.1365-2265.2012.04395.x.
PubMed 22443308Wang PH, Wu TY, Chen YL, Gicana RG, Lee TH, Chen MJ, Hsiao TH, Lu MJ, Lai YL, Wang TY, Li JY, Chiang YR. Bacterial estrogenesis without oxygen: Wood-Ljungdahl pathway likely contributed to the emergence of estrogens in the biosphere. Proc Natl Acad Sci U S A. 2025 Mar 11;122(10):e2422930122. doi: 10.1073/pnas.2422930122. Epub 2025 Mar 7.
PubMed 40053361Hsiao TH, Chou CH, Chen YL, Wang PH, Brandon-Mong GJ, Lee TH, Wu TY, Li PT, Li CW, Lai YL, Tseng YL, Shih CJ, Chen PH, Chen MJ, Chiang YR. Circulating androgen regulation by androgen-catabolizing gut bacteria in male mouse gut. Gut Microbes. 2023 Jan-Dec;15(1):2183685. doi: 10.1080/19490976.2023.2183685.
PubMed 36843073Chen MJ, Chou CH, Hsiao TH, Wu TY, Li CY, Chen YL, Chao KH, Lee TH, Gicana RG, Shih CJ, Brandon-Mong GJ, Lai YL, Li PT, Tseng YL, Wang PH, Chiang YR. Clostridium innocuum, an opportunistic gut pathogen, inactivates host gut progesterone and arrests ovarian follicular development. Gut Microbes. 2024 Jan-Dec;16(1):2424911. doi: 10.1080/19490976.2024.2424911. Epub 2024 Nov 7.
PubMed 39508647Chen MJ, Chen CD, Yang JH, Chen CL, Ho HN, Yang WS, Yang YS. High serum dehydroepiandrosterone sulfate is associated with phenotypic acne and a reduced risk of abdominal obesity in women with polycystic ovary syndrome. Hum Reprod. 2011 Jan;26(1):227-34. doi: 10.1093/humrep/deq308. Epub 2010 Nov 18.
PubMed 21088016Chen MJ, Yang WS, Chen CL, Wu MY, Yang YS, Ho HN. The relationship between anti-Mullerian hormone, androgen and insulin resistance on the number of antral follicles in women with polycystic ovary syndrome. Hum Reprod. 2008 Apr;23(4):952-7. doi: 10.1093/humrep/den015. Epub 2008 Feb 6.
PubMed 18256110Chen MJ, Chou CH, Chen SU, Yang WS, Yang YS, Ho HN. The effect of androgens on ovarian follicle maturation: Dihydrotestosterone suppress FSH-stimulated granulosa cell proliferation by upregulating PPARgamma-dependent PTEN expression. Sci Rep. 2015 Dec 17;5:18319. doi: 10.1038/srep18319.
PubMed 26674985Wu CE, Huang CC, Hsiao YJ, Hsu CL, Chen TH, Chen MJ, Ho HN. Pathophysiology of androgen-associated endothelial cell dysfunction in phenotype A polycystic ovarian syndrome revealed by iPSCs modeling. Front Endocrinol (Lausanne). 2026 Feb 12;17:1682793. doi: 10.3389/fendo.2026.1682793. eCollection 2026.
PubMed 41767389Chou CH, Chen MJ. The Effect of Steroid Hormones on Ovarian Follicle Development. Vitam Horm. 2018;107:155-175. doi: 10.1016/bs.vh.2018.01.013. Epub 2018 Feb 9.
PubMed 29544629Chen MJ, Yang WS, Yang JH, Hsiao CK, Yang YS, Ho HN. Low sex hormone-binding globulin is associated with low high-density lipoprotein cholesterol and metabolic syndrome in women with PCOS. Hum Reprod. 2006 Sep;21(9):2266-71. doi: 10.1093/humrep/del175. Epub 2006 Jun 6.
PubMed 16757555Huang CC, Tien YJ, Chen MJ, Chen CH, Ho HN, Yang YS. Symptom patterns and phenotypic subgrouping of women with polycystic ovary syndrome: association between endocrine characteristics and metabolic aberrations. Hum Reprod. 2015 Apr;30(4):937-46. doi: 10.1093/humrep/dev010. Epub 2015 Feb 6.
PubMed 25662806Chen MJ, Yang WS, Yang JH, Chen CL, Ho HN, Yang YS. Relationship between androgen levels and blood pressure in young women with polycystic ovary syndrome. Hypertension. 2007 Jun;49(6):1442-7. doi: 10.1161/HYPERTENSIONAHA.106.083972. Epub 2007 Mar 26.
PubMed 17389259
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Androgen Levels Via Probiotics Supplementation: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT07911813
- Acronym / sponsor ID
- 202607031RIPB
- Conditions
- Androgen Levels
- Keywords
- Bacillus coagulans, BRCAS-C3, Probiotics, Androgen Levels, Testosterone, Dihydrotestosterone, Gut Microbiota, Pilot Study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- GeneFerm Biotechnology Co., Ltd.
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- 13 Aug 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BRCAS-C3 Probiotic Supplementation | Experimental | Dietary Supplement: Bacillus coagulans BRCAS-C3Participants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women aged between 18-45 y/o.
- For women: Total testosterone > 0.7 ng/mL or free androgen index (FAI) > 6.1. For Men: Total testosterone level within NTUH Department of Laboratory Medicine reference ranges (2.40 - 8.71 ng/mL).
- Willingness to maintain their baseline diet, physical activity levels and skin care routines throughout the 24 weeks study duration.
- Understand the study protocols and provide written informed consent.
- For female participants with childbearing potential: Agreement to use non-hormonal contraception throughout the study.
Key exclusion criteria (8 listed)
- Medication/Interventions: Use of hormonal contraceptives, ovulation induction agents, anti-androgens (e.g., spironolactone, finasteride, flutamide, oral retinoic acid, cyproterone acetate), metformin, GLP-1 receptor agonists, systemic steroids, or traditional Chinese medicine (TCM) formulations derived for endocrine, metabolic, or weight-loss purposes within the past 3 months.
- History of benign prostatic hyperplasia (BPH), prostate cancer, or other urological diseases, with use of GnRH agonists (e.g., leuproreline, goserelin, triptorelin), first-generation anti-androgens (e.g., cyproterone acetate, bicalutamide), or second-generation anti-androgens (e.g., abiraterone, enzalutamide, apalutamide) within the past 6 months.
- Antibiotics/Probiotics Washout: Use of systemic antibiotics, antifungals, or commercial high dose probiotic supplements within the past 4 weeks prior to baseline.
- Gastrointestinal Disorders: History of severe chronic gastrointestinal diseases such as Inflammatory bowel disease, Celiac disease, colon cancer, or major bowel surgery that significantly alter nutrient absorption.
- Endocrine pathologies as androgen-secreting tumor, Cushing syndrome, or untreated thyroid disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus coagulans BRCAS-C3Bacillus 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. | Dietary supplement | BRCAS-C3 Probiotic Supplementation |
Primary outcome
Change in Serum Total Testosterone from Baseline to Week 24
Time frame: Baseline, Week 12 and 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 32660613Yang PK, Chou CH, Chang CH, Chen SU, Ho HN, Chen MJ. Changes in peripheral mitochondrial DNA copy number in metformin-treated women with polycystic ovary syndrome: a longitudinal study. Reprod Biol Endocrinol. 2020 Jul 13;18(1):69. doi: 10.1186/s12958-020-00629-5.
- Background: PubMed 29325133Yang PK, Hsu CY, Chen MJ, Lai MY, Li ZR, Chen CH, Chen SU, Ho HN. The Efficacy of 24-Month Metformin for Improving Menses, Hormones, and Metabolic Profiles in Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2018 Mar 1;103(3):890-899. doi: 10.1210/jc.2017-01739.
- Background: PubMed 24220143Hashemi S, Ramezani Tehrani F, Noroozzadeh M, Azizi F. Normal cut-off values for hyperandrogenaemia in Iranian women of reproductive age. Eur J Obstet Gynecol Reprod Biol. 2014 Jan;172:51-5. doi: 10.1016/j.ejogrb.2013.09.029. Epub 2013 Oct 19.
- Background: PubMed 22443308Zhou Z, Ni R, Hong Y, Li Y, Wang Y, Zhao X, Yang D. Defining hyperandrogenaemia according to the free androgen index in Chinese women: a cross-sectional study. Clin Endocrinol (Oxf). 2012 Sep;77(3):446-52. doi: 10.1111/j.1365-2265.2012.04395.x.
- Background: PubMed 40053361Wang PH, Wu TY, Chen YL, Gicana RG, Lee TH, Chen MJ, Hsiao TH, Lu MJ, Lai YL, Wang TY, Li JY, Chiang YR. Bacterial estrogenesis without oxygen: Wood-Ljungdahl pathway likely contributed to the emergence of estrogens in the biosphere. Proc Natl Acad Sci U S A. 2025 Mar 11;122(10):e2422930122. doi: 10.1073/pnas.2422930122. Epub 2025 Mar 7.
- Background: PubMed 36843073Hsiao TH, Chou CH, Chen YL, Wang PH, Brandon-Mong GJ, Lee TH, Wu TY, Li PT, Li CW, Lai YL, Tseng YL, Shih CJ, Chen PH, Chen MJ, Chiang YR. Circulating androgen regulation by androgen-catabolizing gut bacteria in male mouse gut. Gut Microbes. 2023 Jan-Dec;15(1):2183685. doi: 10.1080/19490976.2023.2183685.
- Background: PubMed 39508647Chen MJ, Chou CH, Hsiao TH, Wu TY, Li CY, Chen YL, Chao KH, Lee TH, Gicana RG, Shih CJ, Brandon-Mong GJ, Lai YL, Li PT, Tseng YL, Wang PH, Chiang YR. Clostridium innocuum, an opportunistic gut pathogen, inactivates host gut progesterone and arrests ovarian follicular development. Gut Microbes. 2024 Jan-Dec;16(1):2424911. doi: 10.1080/19490976.2024.2424911. Epub 2024 Nov 7.
- Background: PubMed 21088016Chen MJ, Chen CD, Yang JH, Chen CL, Ho HN, Yang WS, Yang YS. High serum dehydroepiandrosterone sulfate is associated with phenotypic acne and a reduced risk of abdominal obesity in women with polycystic ovary syndrome. Hum Reprod. 2011 Jan;26(1):227-34. doi: 10.1093/humrep/deq308. Epub 2010 Nov 18.
- Background: PubMed 18256110Chen MJ, Yang WS, Chen CL, Wu MY, Yang YS, Ho HN. The relationship between anti-Mullerian hormone, androgen and insulin resistance on the number of antral follicles in women with polycystic ovary syndrome. Hum Reprod. 2008 Apr;23(4):952-7. doi: 10.1093/humrep/den015. Epub 2008 Feb 6.
- Background: PubMed 26674985Chen MJ, Chou CH, Chen SU, Yang WS, Yang YS, Ho HN. The effect of androgens on ovarian follicle maturation: Dihydrotestosterone suppress FSH-stimulated granulosa cell proliferation by upregulating PPARgamma-dependent PTEN expression. Sci Rep. 2015 Dec 17;5:18319. doi: 10.1038/srep18319.
- Background: PubMed 41767389Wu CE, Huang CC, Hsiao YJ, Hsu CL, Chen TH, Chen MJ, Ho HN. Pathophysiology of androgen-associated endothelial cell dysfunction in phenotype A polycystic ovarian syndrome revealed by iPSCs modeling. Front Endocrinol (Lausanne). 2026 Feb 12;17:1682793. doi: 10.3389/fendo.2026.1682793. eCollection 2026.
- Background: PubMed 29544629Chou CH, Chen MJ. The Effect of Steroid Hormones on Ovarian Follicle Development. Vitam Horm. 2018;107:155-175. doi: 10.1016/bs.vh.2018.01.013. Epub 2018 Feb 9.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mei-Jou Chen principal investigator
Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei 100, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacillus coagulans BRCAS-C3 in people with Androgen Levels, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei-Jou Chen, MD, PhD (+886 972651979, mjchen04@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Total Testosterone from Baseline to Week 24 (time frame: Baseline, Week 12 and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07911813, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.