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

NCT ID: NCT06440486

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2024-12-15

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Probiotics

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

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: DIETARY_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.

Maltodextrin

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

Group Type: PLACEBO_COMPARATOR

Probiotics

Intervention Type: DIETARY_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.

Interventions

Probiotics

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wecare Probiotics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanchong Central Hospital

Nanchong, Sichuan, China

Countries

China

Central Contacts

Kang Liu, Doctor

Role: CONTACT

liukang@nsmc.edu.cn

15808432375 ext. ＋86

Facility Contacts

Kang Liu

Role: primary

liukang@nsmc.edu.cn

15808432375

Other Identifiers

WK2024008

Identifier Type: -

Identifier Source: org_study_id