Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes

NCT06901791 | Recruiting

• 1 other identifier: WK20250321
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Blood glucose change

  Assess and evaluate the improvement of patients' fasting blood glucose levels before the intervention begins, during the intervention, and after the intervention ends.

  16 weeks

Study Arms (2)

Probiotic Group

EXPERIMENTAL

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.

Dietary Supplement: Conventional treatment and Probiotic

Placebo Group

NO INTERVENTION

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

Interventions

Conventional treatment and Probiotic DIETARY_SUPPLEMENT

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

Probiotic Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Xiao Wu, Doctor

CONTACT

13451682617; szslwx@126.com

Xiao Wu

CONTACT

13451682617; szslwx@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 30, 2025
• Study Start: April 10, 2025
• Primary Completion: July 31, 2025
• Study Completion: March 10, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CN (1)