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Clinical Trials in China / NCT06938464
Recruiting Not applicable

Preventive Effect of Probiotics in GDM

NCT06938464 · tracked via the Priya Life Science China tracker
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Phase
Not applicable
Started
2023-10-27
Last updated
2025-04-27

Condition(s) studied

Gestational Diabetes Mellitus (GDM)

Investigational drug(s) / intervention(s)

ProbioticsPlacebo

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

Placebo: placebo with similar appearance and smell but not containing probiotics

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study. 1. included between 12-16 gestational weeks 2. A woman was considered high risk when her pre-pregnancy BMI ≥ 24 kg/m\^2, having family history of diabetes (type 1 or 2), GDM or PCOS (polycystic ovary syndrome) history, history of delivering macrosomia or stillbirth, or glucose in urine (+) Exclusion Criteria: 1. Taking probiotics or prebiotics within the past month 2. Have a history of allergies to the drug components or similar drugs in this study 3. Having long-term smoking or drinking habits 4. Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy 5. Diseases in other important organs such as heart, liver, and kidney 6. with clear digestive system diseases 7. Multiple pregnancy 8. with mental or cognitive impairments who are unable to complete this study

Primary outcome measure(s)

  • the incidence of gestational diabetes — 24-28th weeks gestation
    The number of cases and incidence of gestational diabetes according to OGTT

Trial sites (1)

FacilityCityRegionStatus
Women's Hospital Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting

More Women's Hospital School Of Medicine Zhejiang University trials in China

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Association of Gestational Cardiovascular Health With Pregnancy Outcomes Recruiting
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Predicting Treatment Failure in HSIL Patients with Positive Margins After Conization Via Detection of PAX1 Methylation Starting soon
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions Recruiting

Other trials for the same condition

The WAIT Trial: Waiting Versus Active Induction at Term in Women With A1 Gestational Diabetes Mellitus Starting soon
Long-term Evaluation of Gestational Endocrine & Metabolic Dynamics Recruiting
Digital Health Intervention for Early Identification and Prevention of Gestational Diabetes Mellitus Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06938464 on ClinicalTrials.gov ↗ ← All trials in China