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

Wecare Probiotics

Status: Not yet enrolling

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Industry

Identifiers

NCT06440486

WK2024008

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

Participants will receive a probiotic strip (3g/strip) daily alongside their standard clinical treatment for a continuous 12-week period.

Treatment:

Dietary Supplement: Probiotics

Maltodextrin

Placebo Comparator group

Description:

Participants will take a daily placebo strip (3g/strip) in addition to their regular clinical treatment over a continuous 12-week period.

Treatment:

Dietary Supplement: Probiotics