Polycystic Ovary Syndrome
Conditions
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.
Interventions
0.5g (1 pill) of Metformin tablets administered three times a day orally before meal
DRUGProMetS probiotics powder
4g (2 strips) of ProMetS probiotics powder administered orally every night
DRUG1. Metformin tablets; 2. 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
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Serum follicle-stimulating hormone levels | 12 weeks | — |
| Serum luteinizing hormone levels | 12 weeks | — |
| Serum estradiol levels | 12 weeks | — |
| Gut microbiota | 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 testosterone levels | 12 weeks | — |
| Fasting glucose levels | 12 weeks | — |
| Fasting insulin levels | 12 weeks | — |
Countries
China
Contacts
Primary ContactDalong Zhu, MD, PhD
Outcome results
None listed