Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes
ConditionGDM
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorWecare Probiotics Co., Ltd.
About this trial
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
This trial accepts healthy volunteersQualifiers
Women diagnosed with gestational diabetes mellitus (GDM) at 24 weeks of gestation.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Conventional treatment and Probiotic
Dietary supplementParticipants will continuously take Lactobacillus rhamnosus LRa05 from the time of enrollment until delivery.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Probiotic GroupExperimental treatment 1 intervention
Group B: Placebo GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov