Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes

Inclusion criteria

• 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.

Exclusion criteria

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