Clinical Research Directory
Browse clinical research sites, groups, and studies.
Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome
Sponsor: Shanghai Changzheng Hospital
Summary
This single-center, prospective, two-stage clinical trial aims to evaluate the safety, preliminary efficacy, and reproductive outcomes of oral Fecal Microbiota Transplantation (FMT) freeze-dried capsules in overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) undergoing Frozen-Thawed Embryo Transfer (FET).The study is implemented in two sequential phases: Phase Ⅰ (Pilot Exploration): A prospective, open-label, single-arm exploratory study in an initial evaluable cohort ($n=11$) to evaluate preliminary safety, dynamic gut microbiota colonization, endocrine/metabolic parameters, and pregnancy outcomes following FET. Phase Ⅱ (Confirmatory RCT): A prospective, randomized controlled trial (RCT) designed to validate the clinical efficacy and underlying mechanisms of oral FMT capsules compared with control interventions, based on findings established in Phase Ⅰ.
Official title: Fecal Microbiota Transplantation for the Treatment of Polyendocrine Metabolic Ovarian Syndrome in Obese Women:A Phase Ⅰ/ⅡSingle-Arm Pilot Study and Planned Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
20 Years - 40 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-02-21
Completion Date
2028-08-31
Last Updated
2026-08-05
Healthy Volunteers
No
Conditions
Interventions
oral Fecal Microbiota Transplantation
Participants will receive standardized oral FMT freeze-dried powder capsules derived from strictly screened, traceable healthy donors from a standardized Microbiota Biobank. Dosage and Regimen: Oral administration of 5 capsules twice daily on an empty stomach for 6 consecutive days, which constitutes one course. A second identical course will be administered 4 weeks after the completion of the first course (totaling 2 courses). Background: Standardized lifestyle and dietary guidance will be provided throughout the study.
Locations (1)
Center for Reproductive Medicine,Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China