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

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Metformin tablets; Drug: ProMetS probiotics powder; Drug: 1. Metformin tablets; 2. ProMetS probiotics powder

• Registration Number: NCT03336840
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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 administration.

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 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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-05
• Study First Posted: 2017-11-08
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01
• Primary Completion: 2019-03
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin tablets	-
Probiotics	ProMetS probiotics powder	-
Metformin and Probiotics	1. Metformin tablets; 2. ProMetS probiotics powder	-

Primary Outcome Measures

Name	Time	Method
Improvement in menstrual cycle	12 weeks	Patients will be required to maintain a menstrual calendar and record their basal body temperature for the duration of the study and asked to fill a questionnaire before and after study. The questionnaire will cover menstrual cycle dates, duration and amount.
Improvement in hirsutism	12 weeks	Modified Ferriman and Gallwey score (m-FG scores) will be measured before and after study. M-FG score \> 8 is considered hirsutism and when the score is higher, the symptom is more serious.
Improvement in acne score	12 weeks	Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.

Secondary Outcome Measures

Name	Time	Method
Fasting glucose levels	12 weeks
Fasting insulin levels	12 weeks
Gut microbiota	12 weeks
Serum testosterone levels	12 weeks
Serum lipid profiles	12 weeks	including triglycerides (mmol/L), total cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), and high density lipoprotein cholesterol (mmol/L)
Inflammation markers	12 weeks	including C-reactive protein (mg/L)
Immune cells	12 weeks	including count and frequency of T-cell subpopulations like T-regulatory (Treg) cells (/ml), T-helper (Th) cells (/ml)
Serum follicle-stimulating hormone levels	12 weeks
Serum luteinizing hormone levels	12 weeks
Serum estradiol levels	12 weeks

Trial Locations

Locations (1)

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China