Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT06938464

Preventive Effect of Probiotics in GDM

Led by Women's Hospital School Of Medicine Zhejiang University · Updated on 2025-04-27

334

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

Sponsors

W

Women's Hospital School Of Medicine Zhejiang University

Lead Sponsor

Q

Quzhou Maternal and Child Health Care Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Preventive Effect of Probiotics in GDM

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women at high risk for gestational diabetes who agree to participate
  • Between 12 and 16 weeks of gestation
  • High risk defined as having at least one of the following: pre-pregnancy BMI 24 kg/m2 or higher, family history of diabetes (type 1 or 2), history of gestational diabetes or polycystic ovary syndrome, previous delivery of a large baby or stillbirth, or glucose detected in urine
Not Eligible

You will not qualify if you...

  • Taking probiotics or prebiotics within the past month
  • History of allergies to the study's drug components or similar drugs
  • Long-term smoking or drinking habits
  • Diagnosed with type 1 or type 2 diabetes before pregnancy
  • Diseases affecting important organs such as heart, liver, or kidneys
  • Known digestive system diseases
  • Multiple pregnancy
  • Mental or cognitive impairments preventing study completion

AI-Screening

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Trial Site Locations

Total: 1 location

1

Women's Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

D

Danqing Chen, Prof

CONTACT

X

Xinning Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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