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.
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 (+)
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
Parallel
Probiotics
Dietary supplementProbiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid
Placebo
Dietary supplementplacebo with similar appearance and smell but not containing probiotics
the incidence of gestational diabetes
The number of cases and incidence of gestational diabetes according to OGTT
The incidence of macrosomia
macrosomia refers to a newborn weighs more than 4 kg)
Weight gain during pregnancy (kg)
Weight gain during pregnancy (kg) = Maternal weight at delivery - weight pre-pregnancy
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Women's Hospital School Of Medicine Zhejiang University
Lead sponsor
Quzhou Maternal and Child Health Care Hospital
Collaborator
