An interventional study of Probiotics and Placebo in Gestational Diabetes Mellitus (GDM), sponsored by Women's Hospital School Of Medicine Zhejiang University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-04-27.
Sponsored by Women's Hospital School Of Medicine Zhejiang University · Not applicable, Interventional, and Prevention
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.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 334 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study.
Exclusion Criteria:
Probiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT.
Dietary Supplement: Probiotics
Placebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT
Dietary Supplement: Placebo
Probiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid
placebo 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
Time frame: 24-28th weeks gestation
The incidence of macrosomia
macrosomia refers to a newborn weighs more than 4 kg)
Time frame: Delivery
Weight gain during pregnancy (kg)
Weight gain during pregnancy (kg) = Maternal weight at delivery - weight pre-pregnancy
Time frame: Delivery
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Women's Hospital School Of Medicine Zhejiang University