Preventive Effect of Probiotics in GDM

Not Applicable

Recruiting

• Conditions: Gestational Diabetes Mellitus (GDM)

• Registration Number: NCT06938464
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-27
• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 334

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the incidence of gestational diabetes	24-28th weeks gestation	The number of cases and incidence of gestational diabetes according to OGTT

Secondary Outcome Measures

Name	Time	Method
The incidence of macrosomia	Delivery	macrosomia refers to a newborn weighs more than 4 kg)
Weight gain during pregnancy (kg)	Delivery	Weight gain during pregnancy (kg) = Maternal weight at delivery - weight pre-pregnancy

Trial Locations

Locations (1)

Women's Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China