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Completed

NCT Number: NCT07330388

Probiotic Effects in Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Mellitus (Type 2) Antioxidant Effect Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Glucose Metabolism Disorders Inflammation Lipid Metabolism Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Probiotics

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Medicine

Izmir, 35100, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic group

Dietary Supplement

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).

Primary outcomes

  1. Efficacy of probiotics on inflammatory markers

    Time frame: From enrollment to the end of treatment at 12 weeks

    hs-CRP

  2. Efficacy of probiotics on inflammatory markers

    Time frame: From enrollment to the end of treatment at 12 weeks

    Ceruloplasmin

  3. Efficacy of probiotics on antioxydant systems

    Time frame: From enrollment to the end of treatment at 12 weeks

    Glutathion

  4. Efficacy of probiotics on antioxydant systems

    Time frame: From enrollment to the end of treatment at 12 weeks

    malondialdehyde

Secondary outcomes

  1. Efficacy of probiotics on glucose metabolism

    Time frame: From enrollment to the end of treatment at 12 weeks

    Postprandial Blood Glucose

  2. Efficacy of probiotics on glucose metabolism

    Time frame: From enrollment to the end of treatment at 12 weeks

    Fasting Blood Glucose

  3. Efficacy of probiotics on glucose metabolism

    Time frame: From enrollment to the end of treatment at 12 weeks

    HbA1c

  4. Efficacy of probiotics on lipid metabolism

    Time frame: From enrollment to the end of treatment at 12 weeks

    LDL Cholesterol

  5. Efficacy of probiotics on lipid metabolism

    Time frame: From enrollment to the end of treatment at 12 weeks

    HDL Cholesterol

  6. Efficacy of probiotics on lipid metabolism

    Time frame: From enrollment to the end of treatment at 12 weeks

    Triglyceride

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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