Type 2 DiabetesNCT06440486
Assessment of Probiotics on Inflammation and Metabolism in Type 2 Diabetes.
A study testing Probiotics in people with Type 2 Diabetes, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
This clinical study aims to explore the effects of probiotics on inflammatory and metabolic indicators in patients with type 2 diabetes. By assessing the potential of probiotics to modify these markers, the study seeks to identify an economical and effective strategy for the prevention and treatment of type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed an informed consent form before the study and has a thorough understanding of the content, process, and possible adverse reactions of the study;
- Age 18 (inclusive) and above, gender not limited;
- Diagnosed with type 2 diabetes mellitus;
- Not diagnosed with cardiovascular, kidney, or any other diabetic complications.
Who cannot join
- Age over 75 years old;
- Use of exogenous insulin or patients with cardiovascular disease and other complications;
- Patients who are currently using α-glucosidase inhibitors;
- Patients who have a habit of taking probiotics or are currently taking probiotics;
- Pregnant or lactating women;
- Subjects deemed unsuitable for participation in this clinical study by the investigators due to other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanchong Central Hospital
Nanchong, Sichuan, 637000
Kang Liu, 15808432375, liukang@nsmc.edu.cn
About this study
Official title: Based on a Randomized, Double-blind, Controlled Trial, Evaluate the Effects of Probiotics on Inflammation and Metabolism in Patients With Type 2 Diabetes Mellitus.
This clinical study aims to explore the effects of probiotics on inflammatory and metabolic indicators in patients with type 2 diabetes. By assessing the potential of probiotics to modify these markers, the study seeks to identify an economical and effective strategy for the prevention and treatment of type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- Probiotics
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Serum and fecal samples were collected at the beginning and end of the study to evaluate the effects of probiotic consumption on immune markers, metabolites, and gut microbiota before and after administration.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Participants will receive a probiotic strip (3g/strip) daily alongside their standard clinical treatment for a continuous 12-week period. Receives: Dietary Supplement: Probiotics |
| Maltodextrin | Placebo comparator | Participants will take a daily placebo strip (3g/strip) in addition to their regular clinical treatment over a continuous 12-week period. Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
Blood samples will be collected from patients with type 2 diabetes mellitus (T2DM), centrifuged to obtain serum, and analyzed for tumor necrosis factor-alpha (TNF-α), interleukins 6 (IL-6), 10 (IL-10), and 18 (IL-18), IL-1β, and interferon-gamma (IFN-γ) to assess the impact of probiotics on T2DM patients.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start15 Jun 2024 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Participant, Investigator
- 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
- NCT06440486
- Sponsor's protocol ID
- WK2024008
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu S, Qiao Y, He W, Xiao Y, Song G, Liu K, Fang S. Multi-Strain Probiotics BLa80, LRa05, and BBr60 Modulate Inflammation, Bile Acids, and Gut Microbiota in Type 2 Diabetes: A Randomized Controlled Trial. Food Sci Nutr. 2026 Apr 10;14(4):e71735. doi: 10.1002/fsn3.71735. eCollection 2026 Apr.
PubMed 41971606
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Based on a Randomized, Double-blind, Controlled Trial, Evaluate the Effects of Probiotics on Inflammation and Metabolism in Patients With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT06440486
- Acronym / sponsor ID
- WK2024008
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 3 Jun 2024 (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 clinical study aims to explore the effects of probiotics on inflammatory and metabolic indicators in patients with type 2 diabetes. By assessing the potential of probiotics to modify these markers, the study seeks to identify an economical and effective strategy for the prevention and treatment of type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: ProbioticsParticipants will receive a probiotic strip (3g/strip) daily alongside their standard clinical treatment for a continuous 12-week period. |
| Maltodextrin | Placebo comparator | Dietary Supplement: ProbioticsParticipants will take a daily placebo strip (3g/strip) in addition to their regular clinical treatment over a continuous 12-week period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed an informed consent form before the study and has a thorough understanding of the content, process, and possible adverse reactions of the study;
- Age 18 (inclusive) and above, gender not limited;
- Diagnosed with type 2 diabetes mellitus;
- Not diagnosed with cardiovascular, kidney, or any other diabetic complications.
Key exclusion criteria (6 listed)
- Age over 75 years old;
- Use of exogenous insulin or patients with cardiovascular disease and other complications;
- Patients who are currently using α-glucosidase inhibitors;
- Patients who have a habit of taking probiotics or are currently taking probiotics;
- Pregnant or lactating women;
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 |
|---|---|---|
| ProbioticsSerum and fecal samples were collected at the beginning and end of the study to evaluate the effects of probiotic consumption on immune markers, metabolites, and gut microbiota before and after administration. | Dietary supplement | Maltodextrin, Probiotics |
Primary outcome
Inflammatory markers
Time frame: 12 weeks
Blood samples will be collected from patients with type 2 diabetes mellitus (T2DM), centrifuged to obtain serum, and analyzed for tumor necrosis factor-alpha (TNF-α), interleukins 6 (IL-6), 10 (IL-10), and 18 (IL-18), IL-1β, and interferon-gamma (IFN-γ) to assess the impact of probiotics on T2DM patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Derived from this study: PubMed 41971606Zhu S, Qiao Y, He W, Xiao Y, Song G, Liu K, Fang S. Multi-Strain Probiotics BLa80, LRa05, and BBr60 Modulate Inflammation, Bile Acids, and Gut Microbiota in Type 2 Diabetes: A Randomized Controlled Trial. Food Sci Nutr. 2026 Apr 10;14(4):e71735. doi: 10.1002/fsn3.71735. eCollection 2026 Apr.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Type 2 Diabetes, 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kang Liu, Doctor (15808432375 ext. ＋86, liukang@nsmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory markers (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06440486, which also lists 1 linked publication.
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 3 Jun 2024.