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Tests treatment safety and results for GDM
Official title Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes
ClinicalTrials.gov ID: NCT06901791
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Women diagnosed with gestational diabetes mellitus (GDM) at 24 weeks of gestation. Diagnostic criteria for GDM: Abnormal oral glucose tolerance test...
- 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.
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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.
- 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 how well it works.
- Study participants deemed unsuitable by other researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.