The Role of Dysbiosis of Gut Microbiota in the Pathogenesis of PCOS.

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Polycystic ovary syndrome (PCOS) has a significant impact on women's health, but its pathogenesis is not yet clear. Dysbiosis of gut microbiota may play a role in the pathological change of PCOS. Most of the current researches are still limited to the use of amplicon sequencing to compare the basic taxonomic differences of gut microbiota between PCOS patients and normal controls. Overall analysis of microbiome species, genes, function, metabolism, and immunity in PCOS is still lacked. In this research, we would perform metagenomic sequencing to find the characteristics of gut microbiota of PCOS and to explore their correlations with metabolic, immune, and clinical symptoms. Finally, different interventions (lifestyle interventions, lifestyle interventions + oral probiotic, lifestyle interventions+ compound oral contraceptives) would be used to explore the change of gut microbiome in PCOS patients. This research will not only help the understanding of the pathophysiology of PCOS, but also provide a reference for the selection of clinical treatment options.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: Peking Union Medical College
• Treatments: Contraceptive Agents; Contraceptives, Oral; Drospirenone; Drospirenone and ethinyl estradiol combination; Ethinyl Estradiol

Criteria

Inclusion Criteria:

1. Conforms to the 2003 Rotterdam classic PCOS diagnostic criteria.

1. sparse ovulation or anovulation;

2. clinical manifestations of high androgen and/or hyperandrogenism;

3. ovarian polycystic changes: ultrasound suggests one or both sides of the ovary with a diameter of 2-9 mm follicles ≥ 12, and / or ovarian volume ≥ 10 ml;

2 out of 3 items, and exclude other high androgen causes, such as congenital adrenal hyperplasia, Cushing's syndrome, and androgen-secreting tumors;

2. Age: 18-45 years old.

Exclusion Criteria:

1. pregnancy;

2. menopause;

3. adrenal abnormalities;

4. thyroid dysfunction;

5. taking antibiotics for the past 3 months;

6. is taking oral contraceptive treatment;

7. basic diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease, inflammatory bowel disease, etc.);

8. history of smoking;

9. BMI<18kg/m2.