Evaluating Lactobacillus Rhamnosus LRa05 for Gestational Diabetes

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

This study is testing whether a probiotic called Lactobacillus rhamnosus LRa05 can help women with gestational diabetes improve their blood sugar and overall health while they receive standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Wecare Probiotics Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06901791 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of Lactobacillus rhamnosus LRa05 on women diagnosed with gestational diabetes mellitus (GDM). It aims to improve blood glucose levels, gut microbiota, blood lipid levels, inflammatory markers, and body mass index (BMI). Additionally, the study will assess the strain's impact on thyroid function, vaginal microbiota, and bile acid metabolism. Participants will receive conventional treatment alongside the probiotic intervention.

Who should consider this trial

Good fit: Ideal candidates are pregnant women aged 18 to 50 diagnosed with gestational diabetes at 24 weeks of gestation.

Not a fit: Patients with chronic diseases or those who have consumed probiotic-containing foods within two weeks prior to the study may not benefit.

Why it matters

Potential benefit: If successful, this study could provide a novel probiotic treatment option to help manage gestational diabetes and improve maternal and fetal health outcomes.

How similar studies have performed: While the use of probiotics in managing diabetes is an emerging field, this specific approach with Lactobacillus rhamnosus LRa05 is relatively novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. 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).
2. Pregnant women aged 18 to 50 years.
3. Singleton pregnancy with a fetus confirmed to be structurally and chromosomally normal via ultrasound or other prenatal diagnostic methods.
4. No history of chronic diseases, including immune deficiency, hypertension, diabetes, kidney disease, or liver disease.
5. No consumption of probiotic-containing foods (e.g., yogurt, fermented foods, soybean paste) within the two weeks prior to the study.
6. Willing and able to provide written informed consent.
7. Capable of complying with the study protocol and follow-up requirements.

Exclusion Criteria:

1. Those who have taken items with similar functions to the test product in the short term, which may affect the judgment of the results.
2. Those with other endocrine diseases or currently using medications that affect blood glucose control.
3. Those with severe cardiovascular, kidney, or liver diseases.
4. Those with immunodeficiency diseases or currently using immunosuppressive agents.
5. Those with severe gastrointestinal diseases that may affect the absorption or metabolism of probiotics.
6. Those currently using other medications that may affect blood glucose control or lipid levels.
7. Those with a history of allergy to probiotics or any components of the study products.
8. Those with unhealthy lifestyle habits, such as smoking, alcohol consumption, or drug abuse.
9. Those who do not consume the test samples as required or do not follow up on time, resulting in uncertain efficacy.
10. Study participants deemed unsuitable by other researchers.

Where this trial is running

Suzhou, Jiangsu

• Suzhou Municipal Hospital — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Xiao Wu, Doctor

Conditions GDM