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This study evaluates a standardized diagnostic and treatment pathway for polycystic ovary syndrome (PCOS) based on a two-way referral system, comparing approaches with lifestyle changes with or without prebiotic supplementation. It enrolled women aged 18 to 50 diagnosed with PCOS according to the 2003 Rotterdam criteria. It is a study with no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Female participants aged 18-50 years. 2. A diagnosis of PCOS based on the 2003 Rotterdam consensus, meeting at least two of the following three criteria: (i) oligo-ovulation and/or anovulation;(ii) clinical and/or biochemical signs of hyperandrogenism; or(iii) polycystic ovarian morphology on ultrasonography, defined as the presence of ≥12 follicles measuring 2-9 mm in diameter in each ovary and/or an ovarian volume ≥10 cm³. Exclusion Criteria: 1. Patients with other serious medical conditions, including coronary heart disease (e.g., angina pectoris, myocardial infarction, history of coronary revascularization, or abnormal Q waves on electrocardiography), stroke (ischemic or hemorrhagic, including transient ischemic attack), or severe hepatic or renal dysfunction. 2. Patients with eating disorders or severe gastrointestinal diseases that may affect nutritional intervention outcomes. 3. Patients with any other medical condition associated with an estimated life expectancy of less than 5 years. 4. Patients with drug abuse, chronic alcoholism, alcohol dependence, or other addictive tendencies. 5. Patients who are unable to comply with dietary modification or lifestyle intervention or who are unlikely to adhere to follow-up visits. 6. Pregnant or lactating women, or those who have used oral contraceptives or glucagon-like peptide-1 (GLP-1) receptor agonists within the past 3 months. 7. Patients with a known allergy to prebiotics, those who have taken probiotics, prebiotics, or synbiotic supplements within the past 3 months, or those who have used antibiotics within the past 1 month.