Preventive Effect of Probiotics in GDM

Women's Hospital School Of Medicine Zhejiang University

Status: Enrolling

Conditions: Gestational Diabetes Mellitus (GDM)

Treatments: Dietary Supplement: Probiotics; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06938464

IRB-20230226-R

Details and patient eligibility

About

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.

Enrollment: 334 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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334 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Description:

Probiotic powder 1 bag per day, as well as health guidance about diet and exercise. From recruitment until OGTT.

Treatment:

Dietary Supplement: Probiotics

Placebo

Placebo Comparator group

Description:

Placebo 1 bag per day. Similar health guidance about diet and exercise. From recruitment until OGTT

Treatment:

Dietary Supplement: Placebo