Status:
RECRUITING
Preventive Effect of Probiotics in GDM
Lead Sponsor:
Women's Hospital School Of Medicine Zhejiang University
Collaborating Sponsors:
Quzhou Maternal and Child Health Care Hospital
Conditions:
Gestational Diabetes Mellitus (GDM)
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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 (+)
Exclusion
- 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
Key Trial Info
Start Date :
October 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT06938464
Start Date
October 27 2023
End Date
November 1 2026
Last Update
April 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Women's Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000