Status:
UNKNOWN
The Role of Dysbiosis of Gut Microbiota in the Pathogenesis of PCOS.
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Peking Union Medical College
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief 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...
Detailed Description
1. Data quality assurance: ① all inspections and measurements will be performed by either the hospital or the sequencing company personnel according to standard operating procedures (SOPs), except for...
Eligibility Criteria
Inclusion
- Conforms to the 2003 Rotterdam classic PCOS diagnostic criteria.
- sparse ovulation or anovulation;
- clinical manifestations of high androgen and/or hyperandrogenism;
- 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;
- Age: 18-45 years old.
Exclusion
- pregnancy;
- menopause;
- adrenal abnormalities;
- thyroid dysfunction;
- taking antibiotics for the past 3 months;
- is taking oral contraceptive treatment;
- basic diseases of the gastrointestinal tract (ulcerative colitis, Crohn's disease, inflammatory bowel disease, etc.);
- history of smoking;
- BMI\<18kg/m2.
Key Trial Info
Start Date :
February 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03843736
Start Date
February 21 2019
End Date
December 31 2020
Last Update
October 10 2019
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China