Using probiotics to prevent gestational diabetes in pregnant women
The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes
This study is testing if taking probiotics can help prevent gestational diabetes in pregnant women who are at high risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06938464 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with pre-existing diabetes, significant organ diseases, or those who have taken probiotics recently may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.