Preventive Effect of Probiotics in GDM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotics, Placebo.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus (GDM). Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Preventive Effect of Probiotics in Pregnant Women With High-risk for Gestational Diabetes
Overview
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.
Interventions
- Dietary supplement Probiotics
Probiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid - Dietary supplement Placebo
placebo with similar appearance and smell but not containing probiotics
Primary outcome measures
- the incidence of gestational diabetes [Time frame: 24-28th weeks gestation]
Secondary outcome measures (2)
- The incidence of macrosomia [Time frame: Delivery]
- Weight gain during pregnancy (kg) [Time frame: Delivery]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Women's Hospital Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT06938464 · IRB-20230226-R