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the efficacy and safety of fecal microbiota transplantation in the treatment of overweight/obese patients with polycystic ovary syndrome

the efficacy and safety of fecal microbiota transplantation in the treatment of overweight/obese patients with polycystic ovary syndrome

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066953
Enrollment
Unknown
Registered
2022-12-22
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovary syndrome

Interventions

Fetal microbiota transplantation combined with lifestyle intervention group:Fetal microbiota transplantation combined with lifestyle intervention

Sponsors

Shanghai tenth people's hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Women older than 18 and younger than 45 Meet Rotterdam PCOS diagnostic criteria Overweight or obese, BMI = 25kg/m2

Exclusion criteria

Exclusion criteria: Patients with gynecological or gastrointestinal cancer history or family history; Patients with type 1 and type 2 diabetes or diabetes ketoacidosis; Pregnant women; Uncontrolled hypertension (systolic/diastolic blood pressure 140/90mmHg) Active heart disease occurred within 3 months; Inflammatory bowel disease, diabetes gastritis or other serious gastrointestinal diseases; For liver diseases, AST or ALT levels are twice higher than the upper normal limit; For kidney disease, the creatinine clearance rate is lower than 60mL/min; Active or untreated malignant tumor; Combined with intestinal organic or functional diseases; The use of drugs that may interfere with the test results is being used (metformin, Diane 35, etc.) Have received surgical treatment for obesity or FMT treatment; Long term smoking or use of any nicotine product; Alcoholism; Those who need pregnancy and refuse to take reliable contraceptive measures during the study period; Currently or recently participating in another clinical trial.

Design outcomes

Primary

MeasureTime frame
weight;Intestinal flora;

Secondary

MeasureTime frame
waist;hipline;E2;FSH;LH;T;PRL;P;AMH;Glu;insulin;serum cholesterol;triglyceride;HDL;LDL;HOMA-IR;menstrual cycle;ovulation;Androstenedione;DHEA;Sex hormone binding protein;DXA;fibro scan;creatinine;ALT;AST;Urea nitrogen;uric acid;Gynecologic ultrasound;

Countries

China

Contacts

Public ContactXiaowen Shao

Shanghai tenth people's hospital

shaoxiaowen1026@163.com18917682891

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026