Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT06901791

Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes

Led by Wecare Probiotics Co., Ltd. · Updated on 2025-03-30

80

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to comprehensively evaluate the multifaceted impacts of Lactobacillus rhamnosus LRa05 on patients with gestational diabetes. Initially, the study will investigate the effects of LRa05 on improving patients' blood glucose levels and gut microbiota. Additionally, the study will assess the impact of this strain on patients' blood lipid levels, inflammatory markers, and body mass index (BMI). Furthermore, the study will also focus on its effects on thyroid function, vaginal microbiota, and bile acid metabolism in patients with gestational diabetes.

CONDITIONS

Official Title

Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women diagnosed with gestational diabetes mellitus at 24 weeks of gestation based on abnormal oral glucose tolerance test
  • Pregnant women aged 18 to 50 years
  • Singleton pregnancy with fetus confirmed structurally and chromosomally normal by ultrasound or prenatal diagnosis
  • No history of chronic diseases including immune deficiency, hypertension, diabetes, kidney disease, or liver disease
  • No consumption of probiotic-containing foods in the two weeks prior to the study
  • Willing and able to provide written informed consent
  • Able to comply with study protocol and follow-up requirements
Not Eligible

You will not qualify if you...

  • Use of similar functional products to the test product in the short term affecting results
  • Presence of other endocrine diseases or use of medications affecting blood glucose control
  • Severe cardiovascular, kidney, or liver diseases
  • Immunodeficiency diseases or use of immunosuppressive agents
  • Severe gastrointestinal diseases affecting probiotic absorption or metabolism
  • Use of medications that affect blood glucose or lipid levels
  • History of allergy to probiotics or any study product components
  • Unhealthy lifestyle habits such as smoking, alcohol use, or drug abuse
  • Failure to consume test samples as required or failure to follow up on time
  • Participants deemed unsuitable by other researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Actively Recruiting

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Research Team

X

Xiao Wu, Doctor

CONTACT

X

Xiao Wu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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