Using probiotics to prevent gestational diabetes in pregnant women
Official title: The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes
Run by Women's Hospital School Of Medicine Zhejiang University · NCT06938464 · Data updated 2026-11-12
This study is testing if taking probiotics can help prevent gestational diabetes in pregnant women who are at high risk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 334 (estimated) |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | October 27, 2023 |
| Main results expected | November 1, 2025 |
| Study ends | November 1, 2026 |
| Registry record updated | April 27, 2025 |
| Trial ID | NCT06938464 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women between 12-16 weeks of gestation who are identified as high risk for gestational diabetes.
✕Probably not a fit
Patients with pre-existing diabetes, significant organ diseases, or those who have taken probiotics recently may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the preventive effects of probiotics on gestational diabetes mellitus (GDM) in high-risk pregnant women. A total of 334 participants will be randomly assigned to receive either probiotic powder or a placebo from the 12th to the 16th week of gestation until the Oral Glucose Tolerance Test (OGTT) at 24-28 weeks. The study aims to assess the impact of probiotics on glucose regulation and perinatal outcomes, including neonatal weight. The randomized, double-centered, placebo-controlled design enhances the reliability of the findings.
Why it matters
Potential benefit: If successful, this study could provide a novel preventive strategy for managing gestational diabetes, potentially improving maternal and neonatal health outcomes.
How similar studies have gone: While the use of probiotics in pregnancy is an emerging area, similar studies have shown promising results in improving metabolic outcomes, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Women's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Danqing Chen, Prof
- Email: Chendq@zju.edu.cn
- Phone: 86571-87061501
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.