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NCT Number: NCT06938464

Preventive Effect of Probiotics in GDM

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.

Recruiting

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Key information

Conditions

Gestational Diabetes Mellitus (GDM) Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Xinning Chen

CONTACT

[email protected]

+8618817362544

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study.
  • included between 12-16 gestational weeks
  • 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

  • Taking probiotics or prebiotics within the past month
  • Have a history of allergies to the drug components or similar drugs in this study
  • Having long-term smoking or drinking habits
  • Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy
  • Diseases in other important organs such as heart, liver, and kidney
  • with clear digestive system diseases
  • Multiple pregnancy
  • with mental or cognitive impairments who are unable to complete this study

Treatment and study plan

Probiotics

Dietary Supplement

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

Placebo

Dietary Supplement

placebo with similar appearance and smell but not containing probiotics

Primary outcomes

  1. the incidence of gestational diabetes

    Time frame: 24-28th weeks gestation

    The number of cases and incidence of gestational diabetes according to OGTT

Secondary outcomes

  1. The incidence of macrosomia

    Time frame: Delivery

    macrosomia refers to a newborn weighs more than 4 kg)

  2. Weight gain during pregnancy (kg)

    Time frame: Delivery

    Weight gain during pregnancy (kg) = Maternal weight at delivery - weight pre-pregnancy

Study contacts

Contact information is provided by the study sponsor or research team.

Danqing Chen, Prof

CONTACT

[email protected]

86571-87061501

Xinning Chen

CONTACT

[email protected]

+8618817362544

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Collaborators

  • Quzhou Maternal and Child Health Care Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 22, 2025
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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