Red yeast rice to reduce chronic inflammation in PCOS through gut indole metabolism
Official title: Mechanism of Red Yeast Rice Regulating Intestinal Indole Metabolism Pathway to Improve Chronic Inflammation in Polycystic Ovary Syndrome
Run by Sichuan Provincial People's Hospital · NCT07106996 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | Sichuan Provincial People's Hospital Academic / other |
| Locations | 1 site (Lishui, Zhejiang) |
| Status | Recruiting |
| Started | July 28, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | August 1, 2026 |
| Registry record updated | August 6, 2025 |
| Trial ID | NCT07106996 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Lishui Hospital of Traditional Chinese Medicine
Lishui, Zhejiang, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.