The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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 (+)

Locations
Other Locations
China
Women's Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Danqing Chen, Prof
Chendq@zju.edu.cn
86571-87061501
Backup
Xinning Chen
jhviolet@163.com
+8618817362544
Time Frame
Start Date: 2023-10-27
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 334
Treatments
Active_comparator: Probiotics
Probiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT.
Placebo_comparator: Placebo
Placebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT
Related Therapeutic Areas
Sponsors
Leads: Women's Hospital School Of Medicine Zhejiang University
Collaborators: Quzhou Maternal and Child Health Care Hospital

This content was sourced from clinicaltrials.gov