Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes

Официальное название

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

Обзор

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.

Вмешательства

• Пищевая добавка Conventional treatment and Probiotic
  Participants will continuously take Lactobacillus rhamnosus LRa05 from the time of enrollment until delivery.

Первичные конечные точки

• Blood glucose change [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Suzhou Municipal Hospital — Сучжоу

Идентификаторы

NCT: NCT06901791 · WK20250321

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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