Probiotic supplement BRCAS-C3 and its effect on androgen levels

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label pilot study using a pre-post design to explore the feasibility, safety, and preliminary effects of the probiotic Bacillus coagulans strain BRCAS-C3 on circulating androgens in adults aged 18-45. Participants will take the probiotic daily for 24 weeks and complete study visits to measure testosterone and related hormones before and after supplementation. The study will monitor adverse events, especially gastrointestinal symptoms, and assess adherence to the intervention and to baseline lifestyle factors. No placebo or control group is used, so comparisons are within individuals over time. The trial aims to determine feasibility and generate data to inform future controlled studies in men and women with elevated androgen levels.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Department of Obstetrics and Gynecology, National Taiwan University Hospital
  Taipei, Taipei City, Taiwan Recruiting

Study contacts

• Principal investigator: Mei-Jou Chen — Department of Obstetrics and Gynecology, National Taiwan University Hospital, Taipei 100, Taiwan
• Study coordinator: Mei-Jou Chen, MD, PhD
• Email: mjchen04@ntu.edu.tw
• Phone: +886 972651979

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.