Probiotic Effects in Type 2 Diabetes

NCT07330388 | Completed

• 2 other identifiers: 18-4.1/67TGA-2020-20200
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus (Type 2); Inflammation; Probiotics; Antioxidant Effect; Glucose Metabolism; Lipid Metabolism

Outcome Measures

Primary Outcomes (4)

• Efficacy of probiotics on inflammatory markers

  hs-CRP

  From enrollment to the end of treatment at 12 weeks

• Efficacy of probiotics on inflammatory markers

  Ceruloplasmin

  From enrollment to the end of treatment at 12 weeks

• Efficacy of probiotics on antioxydant systems

  Glutathion

  From enrollment to the end of treatment at 12 weeks

• Efficacy of probiotics on antioxydant systems

  malondialdehyde

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (6)

• Efficacy of probiotics on glucose metabolism

  From enrollment to the end of treatment at 12 weeks

• Efficacy of probiotics on glucose metabolism

  From enrollment to the end of treatment at 12 weeks

• Efficacy of probiotics on glucose metabolism

  From enrollment to the end of treatment at 12 weeks

• Efficacy of probiotics on lipid metabolism

  From enrollment to the end of treatment at 12 weeks

• Efficacy of probiotics on lipid metabolism

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients in the control group were not given any additional treatment and were allowed to continue their routine antidiabetic treatment for 12 weeks

Interventions

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).

Probiotic group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University Faculty of Medicine

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Inflammation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• İskender İnce, Assoc. Prof.

  Coordinator of Scientific Research Projects

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof., MD, PhD

Model Details: Participants were allocated sequentially according to order of presentation (alternate allocation). According to the order of presentation to the outpatient clinic, the first patient who met the inclusion criteria was included in the probiotic group and the second patient who presented to the outpatient clinic was included in the control 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 antidiabetic treatment for 12 weeks (Control group).

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 9, 2026
• Study Start: July 1, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)