Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07911813

Effects of Probiotic Supplementation on Androgen Levels

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

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. 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.

Official title: Modulation of Androgen Levels Via Probiotics Supplementation: A Pilot Feasibility Study

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-30

Completion Date

2028-08-30

Last Updated

2026-11-03

Healthy Volunteers

Yes

Conditions

Androgen Levels

Interventions

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.

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.

Locations (1)

Department of Obstetrics and Gynecology, National Taiwan University Hospital

Taipei, Taipei City, Taiwan