Placebo: placebo with similar appearance and smell but not containing probiotics
Study 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
Sex
FEMALE
Min age
18 Years
Max age
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
Primary outcome measure(s)
the incidence of gestational diabetes — 24-28th weeks gestation The number of cases and incidence of gestational diabetes according to OGTT
Trial sites (1)
Facility
City
Region
Status
Women's Hospital Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
More Women's Hospital School Of Medicine Zhejiang University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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