Gestational Diabetes Mellitus (GDM)
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbiotics
Probiotics powder including: Resistant dextrin, inulin, oligosaccharide, erythritol, Lactobacillus plantarum VB165, Bifidobacterium lactis VB301, Lactobacillus rhamnosus VB255, acerola cherry powder, citric acid
DIETARY_SUPPLEMENTPlacebo
placebo with similar appearance and smell but not containing probiotics
Sponsors
Quzhou Maternal and Child Health Care Hospital
Women's Hospital School Of Medicine Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Masking description
The random number table is compiled by the investigator who is specially responsible for grouping and saved. The investigator packaged and coded drugs according to random number table, and recorded. The packaged and numbered drugs are stored in the enrollment office. When the participants meet the inclusion criteria by care providers (doctors), the enrollment office generates a random number for each subject. The participants received the package of drugs according to their random number, and the random number was recorded in the record book. If there are adverse events or the subjects request to withdraw from the trial, the investigator should uncover the blind.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women who meet the high-risk indicators for GDM and agree to participate in this study. 1. included between 12-16 gestational weeks 2. 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
1. Taking probiotics or prebiotics within the past month 2. Have a history of allergies to the drug components or similar drugs in this study 3. Having long-term smoking or drinking habits 4. Type 1 or type 2 diabetes patients with definite diagnosis before pregnancy 5. Diseases in other important organs such as heart, liver, and kidney 6. with clear digestive system diseases 7. Multiple pregnancy 8. with mental or cognitive impairments who are unable to complete this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of gestational diabetes | 24-28th weeks gestation | The number of cases and incidence of gestational diabetes according to OGTT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of macrosomia | Delivery | macrosomia refers to a newborn weighs more than 4 kg) |
| Weight gain during pregnancy (kg) | Delivery | Weight gain during pregnancy (kg) = Maternal weight at delivery - weight pre-pregnancy |
Countries
China
Contacts
Primary ContactDanqing Chen, Prof
Backup ContactXinning Chen
Outcome results
None listed