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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
0.5g (1 pill) of Metformin tablets administered three times a day orally before meal
4g (2 strips) of ProMetS probiotics powder administered orally every night
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
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
RECRUITINGImprovement in menstrual cycle
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.
Time frame: 12 weeks
Improvement in hirsutism
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.
Time frame: 12 weeks
Improvement in acne score
Visual assessment of acne using "mild/moderate/severe" grades will be assessed before and after study.
Time frame: 12 weeks
Gut microbiota
Time frame: 12 weeks
Fasting glucose levels
Time frame: 12 weeks
Fasting insulin levels
Time frame: 12 weeks
Serum follicle-stimulating hormone levels
Time frame: 12 weeks
Serum luteinizing hormone levels
Time frame: 12 weeks
Serum estradiol levels
Time frame: 12 weeks
Serum testosterone levels
Time frame: 12 weeks
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Serum lipid profiles
including triglycerides (mmol/L), total cholesterol (mmol/L), low density lipoprotein cholesterol (mmol/L), and high density lipoprotein cholesterol (mmol/L)
Time frame: 12 weeks
Inflammation markers
including C-reactive protein (mg/L)
Time frame: 12 weeks
Immune cells
including count and frequency of T-cell subpopulations like T-regulatory (Treg) cells (/ml), T-helper (Th) cells (/ml)
Time frame: 12 weeks