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

May 27, 2024 updated by: Wecare Probiotics Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Nanchong, Sichuan, China, 637000
        • Nanchong Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics
Participants will receive a probiotic strip (3g/strip) daily alongside their standard clinical treatment for a continuous 12-week period.
Dietary supplement: 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.
Placebo Comparator: Maltodextrin
Participants will take a daily placebo strip (3g/strip) in addition to their regular clinical treatment over a continuous 12-week period.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2024

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 27, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WK2024008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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