Preventive Effect of Probiotics in GDM

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorWomen's Hospital School Of Medicine Zhejiang University

About this trial

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 criteria

Qualifiers

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/m², 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 (+)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Probiotics
  • Placebo

Treatment groups

334 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Women's Hospital School Of Medicine Zhejiang University

Lead sponsor

Quzhou Maternal and Child Health Care Hospital

Collaborator