RecruitingNot ApplicableNCT06938464

Preventive Effect of Probiotics in GDM

The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Enrollment

334 participants

Start Date

Oct 27, 2023

Study Type

INTERVENTIONAL

Conditions

Gestational Diabetes Mellitus (GDM)

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and Probiotics for people with gestational diabetes mellitus (gdm). The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTProbiotics

Probiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid

DIETARY_SUPPLEMENTPlacebo

placebo with similar appearance and smell but not containing probiotics