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Preventive Effect of Probiotics in GDM

NCT06938464 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2025-04-27

No results posted yet for this study

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.

Conditions

  • Gestational Diabetes Mellitus (GDM)

Interventions

DIETARY_SUPPLEMENT

Probiotics

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

DIETARY_SUPPLEMENT

Placebo

placebo with similar appearance and smell but not containing probiotics

Sponsors & Collaborators

  • Quzhou Maternal and Child Health Care Hospital

    collaborator UNKNOWN

  • Women's Hospital School Of Medicine Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2025-11-01
Completion
2026-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938464 on ClinicalTrials.gov