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Effects of interaction between gut microbiota and gut brain axis regulated by nutrition on metabolism and reproductive endocrine disorders in polycystic ovary syndrome

Effects and mechanisms of interaction between intestinal flora and gut brain axis on metabolism and reproductive endocrine in polycystic ovary syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053801
Enrollment
Unknown
Registered
2021-11-29
Start date
2021-12-15
Completion date
Unknown
Last updated
2022-10-24

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

Conditions

polycystic ovary syndrome (PCOS)

Interventions

Group 1:Dietary fiber
Group 2:Acarbose+Dietary fiber
Group 3:Semaglutide
Group 4:Dulaglutide

Sponsors

Shanghai First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 48 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with PCOS according to Rotterdam diagnostic criteria, adult BMI >= 24kg/m^2, aged 18-48 years; 2. Currently not participating in other research projects, and using contraception during the research period.

Exclusion criteria

Exclusion criteria: 1. Combined with androgen-producing ovarian or adrenal tumors; 2. Combined with Cushing's syndrome, congenital adrenal hyperplasia, hyperprolactinemia and other diseases that cause excess androgen and anovulation; 3. History of insulin sensitizer, corticosteroid and sex hormone therapy within 3 months; 4. Those who have lost weight by any drug method (including appetite suppressants such as fenfluramine, diet pills) or surgery in the past 3 months; 5. Alcoholism (drinking more than 5 times a week, with an average of 2 taels of white wine or half a catty of rice wine or more than 5 bottles of beer each time); 6. Those who received drug treatment for the following diseases in the past 3 months: peptic ulcer, cholecystitis, gallstones, urinary tract infection, acute pyelonephritis, cystitis; 7. Gastrointestinal surgery in the past 1 year, except appendicitis and hernia surgery; 8. Patients with chronic and persistent hepatitis, patients with severe liver diseases such as cirrhosis, and those with abnormal liver function (serum alanine aminotransferase and aspartate aminotransferase are 2.5 times the normal value); 9. Suffering from peptic ulcer, acute and chronic renal insufficiency, uremia; 10. Gallstones, suffering from serious organic diseases such as tumor/cancer, coronary heart disease, myocardial infarction and stroke, etc.; 11. Suffering from infectious diseases such as tuberculosis and AIDS; 12. Epilepsy, congenital heart disease, systemic lupus erythematosus; 13. Aplastic anemia, primary thrombocytopenic purpura, anemia (hemoglobin < 10g/dl); 14. Severe mental illness within the past 6 months; 15. Can not guarantee sufficient time to participate in this project; 16. Pregnancy; 17. There is no guarantee that the dietary intervention will be implemented strictly according to the project requirements.

Design outcomes

Primary

MeasureTime frame
Oral glucose tolerance test insulin;HOMA-IR index;HbA1c;Oral glucose tolerance test blood sugar;HOMA-beta index;Cholesterol;Triglyceride;Low density lipoprotein;High density lipoprotein;Weight;Waistline;Hipline;Body fat distribution;Blood pressure;Intestines secrete peptide;The compositioin of gut microbiota;The metabolism of gut microbiota;Gut microbiota function;Blood chemistry for liver function;Blood chemistry for kidney function;Blood routine;Drug usage;Sex hormone;Serum cortisol;Thyroid function;

Countries

China

Contacts

Public ContactPeng Yongde, Ding Xiaoying

Shanghai First People's Hospital

xiaoyingding@126.com+86 18917227753

Outcome results

None listed

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