Probiotic Effects in Type 2 Diabetes

Ege University

Status: Completed

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

Treatments: Dietary Supplement: Probiotic group

Study type: Interventional

Funder types: Other

Identifiers

NCT07330388

18-4.1/67

TGA-2020-20200 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 77 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Probiotic group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic group

Control group

No Intervention group

Description:

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