Effects of Probiotic Supplementation on Androgen Levels
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.
Gender: All
Ages: 18 Years - 45 Years
