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| ID | Type | Description | Link |
|---|---|---|---|
| TGA-2020-20200 | Other Grant/Funding Number | Ege University Scientific Research Projects Unit |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of probiotics on glucose metabolism | Postprandial Blood Glucose | From enrollment to the end of treatment at 12 weeks |
| Efficacy of probiotics on glucose metabolism | Fasting Blood Glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ä°skender Ä°nce, Assoc. Prof. | Coordinator of Scientific Research Projects | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University Faculty of Medicine | Izmir | 35100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42169191 | Derived | Kilavuz A, Zorbozan O, Yildirim Simsir I, Turgay N, Yilmaz O. Effects of multistrain probiotics on metabolic biomarkers, inflammation, and antioxidant system in patients with type 2 diabetes mellitus: a prospective controlled trial in Turkiye. BMC Nutr. 2026 May 21. doi: 10.1186/s40795-026-01354-9. Online ahead of print. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2018 | Dec 23, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2018 | Dec 23, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 17, 2018 | Dec 23, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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).
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| From enrollment to the end of treatment at 12 weeks |
| Efficacy of probiotics on glucose metabolism | HbA1c | From enrollment to the end of treatment at 12 weeks |
| Efficacy of probiotics on lipid metabolism | LDL Cholesterol | From enrollment to the end of treatment at 12 weeks |
| Efficacy of probiotics on lipid metabolism | HDL Cholesterol | From enrollment to the end of treatment at 12 weeks |
| Efficacy of probiotics on lipid metabolism | Triglyceride | From enrollment to the end of treatment at 12 weeks |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |