GDMNCT06901791
Efficacy of Lactobacillus Rhamnosus LRa05 in Gestational Diabetes
A study testing Conventional treatment and Probiotic in people with GDM, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- GDM
- What is being tested?
- Conventional treatment and Probiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu
Xiao Wu, Doctor, 13451682617 ext. +86, szslwx@126.com
About this study
Official title: Assessing the Efficacy of Lactobacillus Rhamnosus LRa05 in Improving Blood Glucose and Gut Microbiota in Patients With Gestational Diabetes
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
- Being tested
- Conventional treatment and Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional treatment and ProbioticDietary supplement
Participants will continuously take Lactobacillus rhamnosus LRa05 from the time of enrollment until delivery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Conventional treatment and Probiotic |
| Placebo Group | No intervention | Participants will only receive standard treatment (diet control and exercise therapy) until delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start10 Apr 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901791
- Sponsor's protocol ID
- WK20250321
- Status last verified
- Mar 2025
- First submitted
- 23 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Lactobacillus Rhamnosus LRa05 in Improving Blood Glucose and Gut Microbiota in Patients With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06901791
- Acronym / sponsor ID
- WK20250321
- Conditions
- GDM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: Conventional treatment and ProbioticParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional treatment and ProbioticParticipants will continuously take Lactobacillus rhamnosus LRa05 from the time of enrollment until delivery. | Dietary supplement | Probiotic Group |
Primary outcome
Blood glucose change
Time frame: 16 weeks
Assess and evaluate the improvement of patients' fasting blood glucose levels before the intervention begins, during the intervention, and after the intervention ends.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional treatment and Probiotic in people with GDM, run by Wecare Probiotics Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiao Wu, Doctor (13451682617 ext. ＋86, szslwx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose change (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.