Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: Female

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 administration.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Treatments: Diphenhydramine; Metformin; Promethazine

Criteria

Inclusion Criteria:

1. Premenopausal between 18-40 years of age.

2. Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria.

Exclusion Criteria:

1. During the pregnancy and lactation period.

2. Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.

3. Use of antibiotics within 3 months.

4. Symptoms of any infection at screening.

5. Immunodeficient or use of immunosuppressive drugs.

6. Use of products containing prebiotics or probiotics within the last 3 months.

7. Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).

8. Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator