Trials / Recruiting
RecruitingNCT06938464
Preventive Effect of Probiotics in GDM
The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 334 (estimated)
- Sponsor
- Women's Hospital School Of Medicine Zhejiang University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| DIETARY_SUPPLEMENT | Placebo | placebo with similar appearance and smell but not containing probiotics |
Timeline
- Start date
- 2023-10-27
- Primary completion
- 2025-11-01
- Completion
- 2026-11-01
- First posted
- 2025-04-22
- Last updated
- 2025-04-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06938464. Inclusion in this directory is not an endorsement.