Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes

NCT ID: NCT06901791

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2026-03-10

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.

Conditions

GDM

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotic Group

Participants will follow a controlled diet and exercise regimen, while also consuming the probiotic Lactobacillus rhamnosus LRa05 at a dosage of one stick per day (each stick contains 3 grams with 30 billion CFU), continuing until delivery.

Group Type: EXPERIMENTAL

Conventional treatment and Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Participants will continuously take Lactobacillus rhamnosus LRa05 from the time of enrollment until delivery.

Placebo Group

Participants will only receive standard treatment (diet control and exercise therapy) until delivery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Conventional treatment and Probiotic

Participants will continuously take Lactobacillus rhamnosus LRa05 from the time of enrollment until delivery.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiao Wu, Doctor

Role: CONTACT

szslwx@126.com

13451682617 ext. ＋86

Xiao Wu

Role: CONTACT

szslwx@126.com

13451682617 ext. ＋86

Facility Contacts

Xiao Wu, Doctor

Role: primary

szslwx@126.com

13451682617 ext. +86

Other Identifiers

WK20250321

Identifier Type: -

Identifier Source: org_study_id