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0.5g (1 pill) of Metformin tablets administered three times a day orally before meal

Metformin tablets

4g (2 strips) of ProMetS probiotics powder administered orally every night

ProMetS probiotics powder

1. 0.5g (1 pill) of Metformin tablets administered three times a day orally before meal;
2. 4g (2 strips) of ProMetS probiotics powder administered orally every night

1. Metformin tablets; 2. ProMetS probiotics powder

Dalong Zhu, MD, PhD

Dalong Zhu, MD,PhD

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.

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.

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

Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome: a Randomized, Parallel Study

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.

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.

Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.

including triglycerides (mmol/L), total cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), and high density lipoprotein cholesterol (mmol/L)

including count and frequency of T-cell subpopulations like T-regulatory (Treg) cells (/ml), T-helper (Th) cells (/ml)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Chief Physician

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome	NCT03336840	Polycystic Ovar...	Metformin table... ProMetS probiot... 1. Metformin ta...	18 Years - 40 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Effect of Metformin and Probiotics in Reproductive-aged Patients With Polycystic Ovary Syndrome	NCT03336840	Polycystic Ovar...	Metformin table... ProMetS probiot... 1. Metformin ta...	18 Years - 40 Years	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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