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The role of intestinal microbiota disorders in the pathogenesis of polycystic ovary syndrome and the intervention of low-carbohydrate diet

The role of intestinal microbiota disorders in the pathogenesis of polycystic ovary syndrome and the intervention of low-carbohydrate diet

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089854
Enrollment
Unknown
Registered
2024-09-18
Start date
2022-01-21
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovarian syndrome

Interventions

PCOS intervention group:Low carbohydrate diet
PCOS normal weight group:None
PCOS overweight and obesity group:
Healthy control group with normal weight:None
Healthy control group with overweight and obese:None

Sponsors

the First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Observation section: The case group consists of unmarried women aged 18-40 years old, who meet the Rotterdam diagnostic criteria. The control group consists of healthy women with BMI matching. Intervention section: Overweight or obese PCOS patients (BMI = 24 kg/m2) aged 18-40 years who have not yet reached menopause, meet the Rotterdam diagnostic criteria. Good health condition; Thoroughly understand the nature, significance, potential benefits, inconvenience, and potential dangers of the experiment before conducting it; Understand the research procedure and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: Observation section: During pregnancy/lactation period; Suffering from diabetes, hypertension, metabolic syndrome and immune system diseases; Smoking/drinking alcohol; Have taken antibiotics in the past 3 months; Regularly take proton pump inhibitors, laxatives, prebiotics/probiotic products (= 3 times a week); Gastrointestinal diseases (such as inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, etc.) and history of gastrointestinal surgery; Significant changes in dietary structure have occurred in the past three months; Acute infection has occurred in the past 2 weeks. Intervention section: Serious heart, lung, liver, kidney, nerve, mental, infection, and tumor; Pregnancy/lactation period; Suffering from diabetes, hypertension, metabolic syndrome and immune system diseases; Other diseases that cause hyperandrogenism or hyperandrogenism symptoms, such as Cushing's syndrome, non classical congenital adrenal hyperplasia (NCCAH), tumors of the ovaries or adrenal glands that secrete androgens, and drug-induced hyperandrogenism; Other diseases that can cause ovulation disorders such as functional hypothalamic amenorrhea, thyroid disease, hyperprolactinemia, and premature ovarian insufficiency (POI); Smoking/drinking alcohol; Have taken antibiotics in the past 3 months; Regularly take proton pump inhibitors, laxatives, prebiotics/probiotic products (= 3 times a week); Gastrointestinal diseases (such as inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, etc.) and history of gastrointestinal surgery; Significant changes in dietary structure have occurred in the past three months; Acute infection has occurred in the past 2 weeks.

Design outcomes

Secondary

MeasureTime frame
blood glucose;Height, weight, waist circumference, hip circumference, blood pressure, body fat composition;

Primary

MeasureTime frame
basic information of patients;lipid level;Sex hormone;16S rRNA sequencing;Inflammatory factors;Clinical hyperandrogenism performance;Gynecological ultrasound;

Countries

China

Contacts

Public ContactLu Yan

The First Af?liated Hospital of Soochow University

lucia1817@163.com+86 139 6215 8315

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026