Evaluating Lactobacillus Rhamnosus LRa05 for Gestational Diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of Lactobacillus rhamnosus LRa05 on women diagnosed with gestational diabetes mellitus (GDM). It aims to improve blood glucose levels, gut microbiota, blood lipid levels, inflammatory markers, and body mass index (BMI). Additionally, the study will assess the strain's impact on thyroid function, vaginal microbiota, and bile acid metabolism. Participants will receive conventional treatment alongside the probiotic intervention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Suzhou Municipal Hospital
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiao Wu, Doctor
• Email: szslwx@126.com
• Phone: 13451682617

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ASPIRE: Predicting Pregnancy Complications Using Blood and Eye Imaging

  This study tests whether blood and eye imaging biomarkers can predict conditions like preeclampsia, fetal growth restriction, and gestational diabetes in first-time pregnant people carrying one baby.

  Recruiting at 4 sites Medicines360 · Bridgeport, Connecticut and 4 other locations · NCT07669935

• GLOW Plan: Predicting and Preventing Gestational Diabetes with Lifestyle Support and Glucose Monitoring

  This project will test whether combining continuous glucose monitoring, regular self-monitoring, and personalized lifestyle support can help predict and reduce gestational diabetes in pregnant people aged 18–40 who receive care at the participating hospital.

  Recruiting The First Affiliated Hospital with Nanjing Medical University · Nanjing · NCT07263412

• Studying how a mother's glucose control during pregnancy affects her baby's glucose levels after birth

  This study looks at how well a mother's blood sugar is controlled during pregnancy to see if it affects her baby's blood sugar levels after birth.

  Recruiting Cambridge University Hospitals NHS Foundation Trust · Cambridge, Cambridge · NCT04192422

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.