Assessing the Efficacy of Lactobacillus Rhamnosus LRa05 in Improving Blood Glucose and Gut Microbiota in Patients With Gestational Diabetes

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
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• Women diagnosed with gestational diabetes mellitus (GDM) at 24 weeks of gestation.

• Diagnostic criteria for GDM: Abnormal oral glucose tolerance test (OGTT) with an 82.5g glucose load during the 24th week of pregnancy (defined as meeting one or more of the following plasma glucose thresholds: fasting ≥ 5.1 mmol/L, 1-hour ≥ 10 mmol/L, or 2-hour ≥ 8.5 mmol/L).

• Pregnant women aged 18 to 50 years.

• Singleton pregnancy with a fetus confirmed to be structurally and chromosomally normal via ultrasound or other prenatal diagnostic methods.

• No history of chronic diseases, including immune deficiency, hypertension, diabetes, kidney disease, or liver disease.

• No consumption of probiotic-containing foods (e.g., yogurt, fermented foods, soybean paste) within the two weeks prior to the study.

• Willing and able to provide written informed consent.

• Capable of complying with the study protocol and follow-up requirements.

Locations
Other Locations
China
Suzhou Municipal Hospital
RECRUITING
Suzhou
Contact Information
Primary
Xiao Wu, Doctor
szslwx@126.com
13451682617
Backup
Xiao Wu
szslwx@126.com
13451682617
Time Frame
Start Date: 2025-04-10
Estimated Completion Date: 2026-03-10
Participants
Target number of participants: 80
Treatments
Experimental: Probiotic Group
Participants will follow a controlled diet and exercise regimen, while also consuming the probiotic Lactobacillus rhamnosus LRa05 at a dosage of one stick per day (each stick contains 3 grams with 30 billion CFU), continuing until delivery.
No_intervention: Placebo Group
Participants will only receive standard treatment (diet control and exercise therapy) until delivery.
Related Therapeutic Areas
Sponsors
Leads: Wecare Probiotics Co., Ltd.

This content was sourced from clinicaltrials.gov