Status:
UNKNOWN
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to evaluate the safety and effectiveness on the clinical and biological parameters of reproductive-aged PCOS women after a 12-week metformin and/or probiotics adm...
Detailed Description
Probiotics are live bacteria that offer a health benefit to the host when administered in adequate amounts. Probiotic supplementation is safe for use and has demonstrated beneficial effects for metabo...
Eligibility Criteria
Inclusion
- Premenopausal between 18-40 years of age.
- Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.
Exclusion
- During the pregnancy and lactation period.
- Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
- Use of antibiotics within 3 months.
- Symptoms of any infection at screening.
- Immunodeficient or use of immunosuppressive drugs.
- Use of products containing prebiotics or probiotics within the last 3 months.
- Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
- Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03336840
Start Date
June 1 2017
End Date
June 1 2019
Last Update
February 1 2019
Active Locations (1)
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1
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China, 210008