Probiotic Effects in Type 2 Diabetes

January 2, 2026 updated by: Asli Kilavuz, Ege University

The Effects of Probiotics on Metabolic Biomarkers, Inflammation, and the Antioxidant System in Patients With Type 2 Diabetes Mellitus

Adult-onset diabetes is a disease characterized by high blood glucose levels and is one of the leading causes of cardiovascular disease, blindness, end-stage renal failure, and hospitalization. Recent studies support the idea that bacteria found in the gut may play an important role in the development and progression of diabetes. Changes in the gut bacterial environment can affect blood glucose and blood lipids. A increasing number of recent studies have shown that probiotics can alter the gut bacterial environment and reduce blood glucose and blood lipids. The aim of this study is to investigate the effects of probiotics, administered in addition to your current medications, on blood glucose and blood lipids.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants aged 35-65 years diagnosed with T2DM were allocated sequentially according to order of presentation to either probiotic group (n=39) or control group (n=38). The intervention group received a multi-strain probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, twice daily for 12 weeks, while the control group continued standard care. This study evaluated anthropometric measurements, eating attitudes, dietary frequency, quality of life, and physical activity. Biochemical analyses included glycemic control, lipid profiles, inflammation markers (high-sensitivity C-Reactive Protein, Ceruloplasmin), and oxidative stress markers (Malondialdehyde, Glutathione).

Study Type

Interventional

Enrollment (Actual)

77

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 Locations

  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye), 35100
        • Ege University Faculty of Medicine

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:

  • Adults aged 35-65 years
  • Previously diagnosed with T2DM
  • Volunteering to participate in this study.

Exclusion Criteria:

  • Use of any systemic antibiotics, multivitamins, minerals, herbal medicines, prebiotic, probiotic and postbiotic supplements in the last 3-6 months
  • Having a diagnosis of any inflammatory bowel disease, severe renal dysfunction or hepatic dysfunction, immunodeficiency diseases, acute infection, rheumatoid arthritis, cancer history
  • history of alcohol abuse or drug dependence,
  • pregnant or lactating women

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group
Patients in the intervention group were given a probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, each containing 1.25 billion live microorganisms, without vitamins and minerals, twice a day in addition to their current treatment for 12 weeks.
Dietary supplement: Probiotic group
Patients in the intervention group were given a probiotic supplement containing Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis and Lactobacillus paracasei, each containing 1.25 billion live microorganisms, without vitamins and minerals, twice a day in addition to their current treatment for 12 weeks (Probiotic group). Patients in the control group were not given any additional treatment and were allowed to continue their routine antidiabetic treatment for 12 weeks (Control group).
No Intervention: Control group
Patients in the control group were not given any additional treatment and were allowed to continue their routine antidiabetic treatment for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of probiotics on inflammatory markers
Time Frame: From enrollment to the end of treatment at 12 weeks
hs-CRP
From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on inflammatory markers
Time Frame: From enrollment to the end of treatment at 12 weeks
Ceruloplasmin
From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on antioxydant systems
Time Frame: From enrollment to the end of treatment at 12 weeks
Glutathion
From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on antioxydant systems
Time Frame: From enrollment to the end of treatment at 12 weeks
malondialdehyde
From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of probiotics on glucose metabolism
Time Frame: From enrollment to the end of treatment at 12 weeks
Postprandial Blood Glucose
From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on glucose metabolism
Time Frame: From enrollment to the end of treatment at 12 weeks
Fasting Blood Glucose
From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on glucose metabolism
Time Frame: From enrollment to the end of treatment at 12 weeks
HbA1c
From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on lipid metabolism
Time Frame: From enrollment to the end of treatment at 12 weeks
LDL Cholesterol
From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on lipid metabolism
Time Frame: From enrollment to the end of treatment at 12 weeks
HDL Cholesterol
From enrollment to the end of treatment at 12 weeks
Efficacy of probiotics on lipid metabolism
Time Frame: From enrollment to the end of treatment at 12 weeks
Triglyceride
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

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

Sponsor

Ege University

Investigators

  • Study Chair: İskender İnce, Assoc. Prof., Coordinator of Scientific Research Projects

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 (Actual)

July 1, 2020

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-4.1/67
  • TGA-2020-20200 (Other Grant/Funding Number: Ege University Scientific Research Projects Unit)

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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