Clinical Trial

Preventive Effect of Probiotics in GDM

Recruiting
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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.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-14.
Trial Details
NCT Number NCT06938464
Lead Sponsor Women's Hospital School Of Medicine Zhejiang University
Collaborators: Quzhou Maternal and Child Health Care Hospital
Conditions Gestational Diabetes Mellitus (GDM)
Enrollment 334 participants
Start Date 2023-10-27
Primary Completion 2025-11-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-27