Preventive Effect of Probiotics in GDM

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus (GDM)
• Intervention / Treatment: Dietary supplement: Probiotics; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 334
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danqing Chen, Prof; Phone Number: 86571-87061501; Email: Chendq@zju.edu.cn
• Study Contact Backup: Name: Xinning Chen; Phone Number: +8618817362544; Email: jhviolet@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Women's Hospital Zhejiang University School of Medicine
      • Contact: Xinning Chen; Phone Number: +8618817362544; Email: jhviolet@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotics; Probiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT.	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
Placebo Comparator: Placebo; Placebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT	Dietary supplement: Placebo; placebo with similar appearance and smell but not containing probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of gestational diabetes	The number of cases and incidence of gestational diabetes according to OGTT	24-28th weeks gestation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Collaborators: Quzhou Maternal and Child Health Care Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: IRB-20230226-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No