Polycystic Ovary Syndrome (PCOS)
Conditions
Keywords
Polycystic ovary syndrome, red yeast rice, intestinal microbiota, indole metabolism
Brief summary
The aim of this study is to elucidate the effects of red yeast rice on the improvement of symptoms in patients with polycystic ovary syndrome（PCOS）, and to analyze the dose-response relationship between intestinal microbiota and its metabolite, hydroxyindole, and clinical indicators of PCOS. The main questions it aims to answer are: How effective is red yeast rice in treating PCOS? Does the indole metabolic pathway of gut microbiota play a crucial role in the improvement of PCOS symptoms by red yeast rice? Participants will take 6 grams of red yeast rice daily for 6 months, and records will be kept of their PCOS clinical symptoms and indicators before the intervention, at the 3rd month post-intervention, and at the 6th month post-intervention. Additionally, biological samples from feces and serum will be collected at these time points.
Interventions
DRUGred yeast rice，RYR
Participants will take 6 grams of red yeast rice daily for 6 months.
Sponsors
Lishui Hospital of Traditional Chinese Medicine
Sichuan Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hydroxyindole concentration | Baseline, the 3rd month and the 6th month after the intervention | — |
| Prolactin (ng/mL) | Baseline, the 3rd month and the 6th month after the intervention | — |
| follicles number | Baseline, the 3rd month and the 6th month after the intervention | The number of follicles in each ovary of each participant will be determined by ultrasonography. |
| ovarian volume(Length x Width x Thickness/2,ml) | Baseline, the 3rd month and the 6th month after the intervention | The size of each ovary in each participant will be determined by ultrasonography. |
| Follicle diameter(mm) | Baseline, the 3rd month and the 6th month after the intervention | The diameter of the follicles will be determined by ultrasonography. |
| inflammatory marker IL18 [pg/ml] | Baseline, the 3rd month and the 6th month after the intervention | — |
| inflammatory marker IL1β [pg/ml] | Baseline, the 3rd month and the 6th month after the intervention | — |
| testosterone (nmol/l) | Baseline, the 3rd month and the 6th month after the intervention | — |
| Follicle - Stimulating Hormone (mIU/mL) | Baseline, the 3rd month and the 6th month after the intervention | — |
| Luteinizing Hormone (mIU/mL) | Baseline, the 3rd month and the 6th month after the intervention | — |
| Estradiol (pmol/l) | Baseline, the 3rd month and the 6th month after the intervention | — |
| Progesterone (ng/mL) | Baseline, the 3rd month and the 6th month after the intervention | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body-mass-index (BMI) | Baseline, the 3rd month and the 6th month after the intervention | BMI measured with the formula BMI=weight \[kg\]/height² \[m\] |
| waist-to-hip ratio | Baseline, the 3rd month and the 6th month after the intervention | Calculated with the formula: waist circumference/hip circumference |
Other
| Measure | Time frame | Description |
|---|---|---|
| Non-targeted metabolomic analysis of fecal and serum samples | before the intervention, at the 3rd month and the 6th month after the intervention | Fecal and serum samples were subjected to untargeted metabolomic detection using LC-MS/MS with an Agilent UHPLC system coupled to an Agilent 6538 UHD and Accurate-Mass Q-TOF mass spectrometer. Metabolites in the samples were separated, identified, and their information was acquired. Univariate and multivariate analyses were performed on the metabolites to screen for significantly differential metabolites before and after treatment. |
| The metagenomics of fecal samples | before the intervention, at the 3rd month and the 6th month after the intervention | Total DNA of fecal samples is extracted by CTAB method. |
Countries
China
Outcome results
None listed