Preventive Effect of Probiotics in GDM
The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes
Women's Hospital School Of Medicine Zhejiang University
334 participants
Oct 27, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria8
- 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
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06938464