Preventive Effect of Probiotics in GDM

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Gestational Diabetes Mellitus (GDM)

In brief

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.

Key facts

Study ID

NCT06938464

Run by

Women's Hospital School Of Medicine Zhejiang University

People needed

334

Starts

2023-10-27

Expected to finish

2026-11-01

Last updated by the study team

2025-04-27

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 (+)

You may not qualify if…

• 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

Where it is running

• Women's Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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