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Preventive Effect of Probiotics in GDM

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 27, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Secondary endpoints revised (2)v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Gut microbiota is instrumental in the microbial and metabolic network of pregnant women, and is potentially related with gestational diabetes. Perinatal probiotic intervention contributes to improved glucose regulation during pregnancy. Our randomized, double-centered, placebo-controlled study is planned to recruit 334 pregnant women who is in high risk for gestational diabetes. They will be assumed randomly probiotic powder per day or placebo from 12-16th gestational weeks until Oral Glucose Tolerance Test (OGTT) at 24-28th gestational weeks. Perinatal outcomes about neonatal weight will be registered.
Trial Details
NCT Number NCT06938464
Lead Sponsor Women's Hospital School Of Medicine Zhejiang University
Collaborators: Quzhou Maternal and Child Health Care Hospital
Conditions
(from sponsor)		 Gestational Diabetes Mellitus (GDM)
Related terms Diabetes, Gestational
Enrollment 334 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov