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Study on the effects of intestinal bacteria transplantation on glycolipid metabolism and body composition in patients with polycystic ovary syndrome

Study on the effects of intestinal bacteria transplantation on glycolipid metabolism and body composition in patients with polycystic ovary syndrome

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087346
Enrollment
Unknown
Registered
2024-07-25
Start date
2024-07-25
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Polycystic Ovary Syndrome

Interventions

Control group(Drospirenone and Ethinylestradiol Tablets II ):Oral short-acting contraceptive 3 cycles, oral empty capsule excipient 1 course of treatment
Experimental group (Facel Microbiota transplantation +Drospirenone and Ethinylestradiol Tablets II ):Oral intestinal bacteria capsule 1 course, while oral Drospirenone and Ethinylestradiol Tablets II

Sponsors

Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) Polycystic ovary syndrome was confirmed. (2) Age 18-45 years old. (3) No pregnancy plans in the following three months. (4) Abnormal glucose and lipid metabolism. (5) Patients voluntarily participate, sign informed consent, and adhere to treatment follow-up

Exclusion criteria

Exclusion criteria: (1) Severely immunosuppressed patients (neutrophils < 1 500 /mm3, lymphocytes < 500 /mm3). (2) Severe damage of intestinal mucosa. (3) Failure to identify the cause of intestinal mucosal injury. (4) Those currently diagnosed with fulminant colitis or toxic megacolon. (5) Enteral nutrition patients who cannot tolerate 50% of heat calorie requirements due to severe diarrhea, significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high-flow intestinal fistula and other reasons. (6) Patients with severe systemic infection who meet the diagnostic criteria for systemic inflammatory response syndrome. (7) Patients with parenteral organ infection requiring broad-spectrum antibiotic intervention. (8) Patients with severe malnutrition (body mass index < 15 kg/m2) and severe hypoproteinemia (albumin < 25 g/L). (9) Patients with congenital or acquired immunodeficiency. (10) Those who have recently been treated with high-risk immunosuppressive/cytotoxic products, such as rituximab, doxorubicin, or medium-high dose steroid hormones (20 mg/ day or higher) for more than 4 weeks. (11) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Waistline;Body composition analysis;Liver function;Renal function;Total cholesterol;Triglyceride;Low density lipoprotein;High-density lipoprotein;Fasting blood-glucose;Fasting insulin;Fecal genetic testing;

Secondary

MeasureTime frame
Height;Weight;Body Mass Index(BMI);Blood Pressure;Heart rate;Hip cricumference;Blood routine examination;Human Chorionic Gonadotropin, HCG;

Countries

China

Contacts

Public ContactXiangyan Ruan

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

ruanxiangyan@163.com+86 130 1121 5678

Outcome results

None listed

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