Actively Recruiting
Preventive Effect of Probiotics in GDM
Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2025-04-27
334
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
W
Women's Hospital School Of Medicine Zhejiang University
Lead Sponsor
Q
Quzhou Maternal and Child Health Care Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Preventive Effect of Probiotics in GDM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women at high risk for gestational diabetes who agree to participate
- Between 12 and 16 weeks of gestation
- High risk defined as having at least one of the following: pre-pregnancy BMI 24 kg/m2 or higher, family history of diabetes (type 1 or 2), history of gestational diabetes or polycystic ovary syndrome, previous delivery of a large baby or stillbirth, or glucose detected in urine
You will not qualify if you...
- Taking probiotics or prebiotics within the past month
- History of allergies to the study's drug components or similar drugs
- Long-term smoking or drinking habits
- Diagnosed with type 1 or type 2 diabetes before pregnancy
- Diseases affecting important organs such as heart, liver, or kidneys
- Known digestive system diseases
- Multiple pregnancy
- Mental or cognitive impairments preventing study completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Women's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
D
Danqing Chen, Prof
CONTACT
X
Xinning Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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