Based on a Randomized, Double-blind, Controlled Trial, Evaluate the Effects of Probiotics on Inflammation and Metabolism in Patients With Type 2 Diabetes Mellitus.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Wecare Probiotics Co., Ltd.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Inflammatory markers
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Probiotics
Participants will receive a probiotic strip (3g/strip) daily alongside their standard clinical treatment for a continuous 12-week period.
Intervention: Probiotics (Dietary Supplement)
Maltodextrin
Participants will take a daily placebo strip (3g/strip) in addition to their regular clinical treatment over a continuous 12-week period.
Intervention: Probiotics (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported