Assessment of Probiotics on Inflammation and Metabolism in Type 2 Diabetes.

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Probiotics

• Registration Number: NCT06440486
• Lead Sponsor: Wecare Probiotics Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Last Update Submitted: 2024-05-27
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Study Start: 2024-06-15
• Primary Completion: 2024-09-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Signed an informed consent form before the study and has a thorough understanding of the content, process, and possible adverse reactions of the study;
2. Age 18 (inclusive) and above, gender not limited;
3. Diagnosed with type 2 diabetes mellitus;
4. Not diagnosed with cardiovascular, kidney, or any other diabetic complications.

Read More

Exclusion Criteria

1. Age over 75 years old;
2. Use of exogenous insulin or patients with cardiovascular disease and other complications;
3. Patients who are currently using α-glucosidase inhibitors;
4. Patients who have a habit of taking probiotics or are currently taking probiotics;
5. Pregnant or lactating women;
6. Subjects deemed unsuitable for participation in this clinical study by the investigators due to other reasons.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maltodextrin	Probiotics	Participants will take a daily placebo strip (3g/strip) in addition to their regular clinical treatment over a continuous 12-week period.
Probiotics	Probiotics	Participants will receive a probiotic strip (3g/strip) daily alongside their standard clinical treatment for a continuous 12-week period.

Primary Outcome Measures

Name	Time	Method
Inflammatory markers	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.

Trial Locations

Locations (1)

Nanchong Central Hospital; 🇨🇳 Nanchong, Sichuan, China