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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo Group | No Intervention | Participants will only receive standard treatment (diet control and exercise therapy) until delivery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional treatment and Probiotic | Dietary Supplement | Participants will continuously take Lactobacillus rhamnosus LRa05 from the time of enrollment until delivery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion 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 (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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Wu, Doctor | Contact | 13451682617 | +86 | szslwx@126.com |
| Xiao Wu | Contact | 13451682617 | +86 | szslwx@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suzhou Municipal Hospital | Recruiting | Suzhou | Jiangsu | China |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| D019602 |
| Food and Beverages |