Clinical trial NCT06901791: Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes
Official title: Assessing the Efficacy of Lactobacillus Rhamnosus LRa05 in Improving Blood Glucose and Gut Microbiota in Patients With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: GDM
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Blood glucose change
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiang Su
Study officials:
References: