About this trial
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 criteria
Qualifiers
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/m², 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 (+)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Probiotics
- Placebo
Treatment groups
Sponsors and collaborators
Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Quzhou Maternal and Child Health Care Hospital
Collaborator