Red yeast rice to reduce chronic inflammation in PCOS through gut indole metabolism
Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
This trial will test whether taking 6 grams of red yeast rice daily for six months can reduce inflammation and improve symptoms in women aged 18–40 with PCOS by changing gut microbiota indole metabolites.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 1 site (Lishui, Zhejiang) |
| Trial ID | NCT07106996 on ClinicalTrials.gov |
What this trial studies
This early-phase interventional study gives adult women with PCOS 6 grams of red yeast rice daily for six months and tracks clinical signs and inflammatory indicators over time. Measurements are taken at baseline, 3 months, and 6 months, and stool and blood samples are collected at each visit for microbiome sequencing and hydroxyindole metabolite analysis. The trial examines correlations between shifts in the intestinal indole metabolic pathway and changes in PCOS clinical markers to explore a possible mechanism of benefit. Eligible participants meet Rotterdam criteria and must not be pregnant or have used antibiotics or probiotics in the prior three months.
Who should consider this trial
Good fit: Women aged 18–40 who meet the Rotterdam criteria for PCOS, are willing to take daily red yeast rice for six months, and have not used antibiotics or probiotics in the past three months are the intended participants.
Not a fit: Patients who are pregnant, have recent antibiotic or probiotic use, active infections, or severe multi-organ dysfunction are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could provide a microbiome-targeting, dietary-derived option to lower inflammation and improve PCOS symptoms.
How similar studies have performed: Red yeast rice is well studied for lipid lowering and there is growing evidence that microbiota-targeted interventions can improve metabolic features in PCOS, but using gut indole metabolism as the primary mechanism in PCOS is novel and not well tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Female patients aged 18-40 years old * Meeting the Rotterdam criteria (at least two of the following): * Anovulation or oligo-ovulation * Clinical evidence of hyperandrogenism or hyperandrogenemia * Ultrasound findings indicating polycystic ovarian morphology (defined as at least 12 follicles measuring 2-9 mm in diameter and/or an ovarian volume \>10 mL \[length × width × thickness / 2\] in one ovary) * Subjects who have been fully informed of the study procedures and related risks, and voluntarily agree to participate Exclusion Criteria * Pregnant women (confirmed via urine/serum hCG) * Patients with concomitant infectious diseases or severe dysfunction of multiple systemic organs * Patients who have taken antibiotics or other drugs (such as probiotics, prebiotics, etc.) that can alter the composition of intestinal flora within 3 months before enrollment
Where this trial is running
Lishui, Zhejiang
- Lishui Hospital of Traditional Chinese Medicine — Lishui, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.