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

Nanjing University

Status: Unknown

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: ProMetS probiotics powder; Drug: Metformin tablets; Drug: 1. Metformin tablets; 2. ProMetS probiotics powder

Study type: Interventional

Funder types: Other

Identifiers

NCT03336840

PCOS2017

Details and patient eligibility

About

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.

Full 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 metabolic diseases such as obesity and diabetes. In this study, about 90 reproductive-aged women with PCOS will be enrolled. Participants will be randomly assigned into one of the following three groups: Metformin tablets (0.5g tid po), ProMetS probiotics powder (4g qN po), Metformin tablets (0.5g tid po) and ProMetS probiotics powder (4g qN po), for 12 weeks. Blood and stool samples will be collected before and after treatment. Fasting glucose levels, fasting insulin levels, sex hormone levels, serum lipid profiles, inflammation markers, other metabolic related parameters and change of gut microbiota and immune cells will be evaluated.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Metformin

Experimental group

Treatment:

Drug: Metformin tablets

Probiotics

Experimental group

Treatment:

Drug: ProMetS probiotics powder

Metformin and Probiotics

Experimental group

Treatment:

Drug: 1. Metformin tablets; 2. ProMetS probiotics powder