polycystic ovary syndrome
Conditions
Interventions
Test group:Keywords ketogenic diet
control group:Ketogenic diet
control group:placebo
Sponsors
Soochow University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years, female; 2. Patients diagnosed with PCOS according to the 2003 European Society for human reproduction and embryology and American Society of reproductive medicine (eshre/asrm) Rotterdam criteria; 3. BMI >= 28; 4. Good organ function: (1) Neutrophil absolute value >= 1.5x10^9/L; (2) Platelet count >= 100x10^9/L; (3) Hemoglobin >= 90 g/L; (4) Total bilirubin = 50 ml/min. 5. Patients must agree to use reliable physical contraceptive methods with their partners during the trial and no less than 30 days after the end of the trial; 6. The patient must agree to suspend the drugs that affect the menstrual cycle such as gynecological endocrinology and the intervention measures that affect the body mass such as acupuncture and catgut embedding during the trial; 7. Volunteer to participate in the study and sign the informed consent, and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Long term regular use of Bifidobacterium infantum b8762 or dairy products containing Bifidobacterium infantum b8762; 2. Patients with oral ulcer and serious gum and periodontal disease; 3. Unable to cooperate with the person completing the stool specimen collection; 4. Pregnant or lactating women or those planning to become pregnant during the study period; 5. Participated in other clinical trials within 12 weeks before enrollment; 6. Patients with high-grade epithelial neoplasia of endometrium who must be treated with high-efficiency progesterone; 7. Heart disease with impaired cardiac function or significant clinical significance; 8. There are serious or uncontrollable diseases, including but not limited to: (1) Uncontrollable nausea, vomiting, anorexia, unable to cooperate with nutritional treatment; (2) Have a history of immunodeficiency, including HIV antibody test positive; (3) Active hepatitis B and hepatitis C virus infection; (4) Serious complications and basic diseases, such as liver and kidney failure, cardiopulmonary failure, cardiovascular and cerebrovascular disease (acute stage); (5) Severe atherosclerotic plaques are at risk of shedding; (6) Patients with malignant tumor or history of malignant tumor, especially those with B-Raf V600E mutation; (7) Severe autoimmune diseases, such as tuberous sclerosis and systemic lupus erythematosus. 9. The investigator considers that the subject has other serious systemic disease history and is not suitable for participating in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Demographic information;Anthropometric index;routine blood test;Blood biochemistry;Imaging examination; | — |
Countries
China
Contacts
Public ContactAili Wang
Soochow University
Outcome results
None listed