Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome | NCT07746635

NCT07746635

Overview

NCT ID: NCT07746635
Lead Sponsor: Shanghai Changzheng HospitalOTHER
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
Brief 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.

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Feb 21, 2025Actual
Primary Completion Date: Aug 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

1. Females aged 20 to 40 years old.

2. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS).

3. Body Mass Index (BMI): >24 kg/m²(covering overweight and obese patients according to Asian criteria, addressing the actual recruited cohort ranging from 24 kg/m² upwards).

4. Scheduled to undergo Frozen-Thawed Embryo Transfer (FET) at the Reproductive Medicine Center.

5. Voluntary participation with signed Informed Consent Form (ICF).

Exclusion Criteria:

Age < 20 or > 40 years.

Pregnancy or lactation.

Other endocrine disorders (e.g., Cushing's syndrome, thyroid dysfunction); severe organ dysfunction or impaired intestinal mucosal barrier; use of antibiotics, probiotics, or prebiotics within 1 month.

Use of ovulation-modifying or anti-androgen drugs within 3 months; severe psychiatric disorders.

Concurrent participation in other clinical trials.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Sequential Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Ningxia Sun, ChiefContact
suesunchzh@126.com

Similar Studies

NCT02741518Completed

Fecal Microbiota Transplantation for the Treatment of Obesity

NCT03325023Unknown status

Effect of Dietary Modifacation on Microbiota in Overweight and Obese Polycystic Ovary Syndrome Patients

NCT03477916Completed

Fecal Microbial Transplantation and Fiber Supplementation in Participants With Obesity and Metabolic Syndrome.

NCT03642600Completed

The Gut Microbiome in Women With Polycystic Ovary Syndrome

NCT03843736Unknown status

The Role of Dysbiosis of Gut Microbiota in the Pathogenesis of PCOS.

NCT06551285Recruiting

Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome.

NCT03127696Completed

Randomised Placebo-controlled Study of FMT to Impact Body Weight and Glycemic Control in Obese Subjects With T2DM

NCT03789461Unknown status

Fecal Microbiota Transplant (FMT) to Induce Weight Loss in Obese Subjects