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Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome

Study acronym: FMT-PMOS
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 31, 2028 → Dec 31, 2028
See other at-risk trials from Shanghai Changzheng Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment increased: 161 → 201 participants
    • Eligibility criteria expanded, about 7 words
  2. Start date: Feb 21, 2025 to Apr 15, 2025
    • Primary and study completion pushed from Aug 31, 2028 to Dec 31, 2028
    v3
  3. Enrollment increased: 60 → 161 participants
    • Trial arms changed: 1 → 2
    • Interventions: oral Fecal Microbiota Transplantation (Biological) to Placebo (Other), oral Fecal Microbiota Transplantation (Biological)
    • Study description shortened, about 2 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This 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 planned multicenter, 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.
Trial Details
NCT Number NCT07746635
Lead Sponsor Shanghai Changzheng Hospital
Conditions
(from sponsor)		 PCOS (Polycystic Ovary Syndrome)
Related terms Polycystic Ovary Syndrome
Enrollment 201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov