Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes

Launched by WECARE PROBIOTICS CO., LTD. · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a specific probiotic called Lactobacillus rhamnosus LRa05 on women who have been diagnosed with gestational diabetes mellitus (GDM), a type of diabetes that can occur during pregnancy. The researchers want to see if this probiotic can help improve blood sugar levels, cholesterol levels, and other health markers related to GDM. They will also look at how the probiotic affects gut health and other bodily functions during pregnancy.

To participate in this study, women should be between 18 and 50 years old and have been diagnosed with GDM around 24 weeks of pregnancy. They should be having a healthy pregnancy with one baby and no serious health issues. Participants will need to provide consent and follow the study guidelines. Throughout the trial, they will take the probiotic and attend follow-up appointments to monitor their health and any changes. This study is currently looking for participants, so if you or someone you know meets the criteria, it could be an opportunity to contribute to important research on managing gestational diabetes.

Gender

ALL

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.