Assessment of Probiotics on Inflammation and Metabolism in Type 2 Diabetes.

Based on a Randomized, Double-blind, Controlled Trial, Evaluate the Effects of Probiotics on Inflammation and Metabolism in Patients With Type 2 Diabetes Mellitus.

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06440486

Enrollment

Registered

2024-06-03

Start date

2024-06-15

Completion date

2024-12-15

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

This clinical study aims to explore the effects of probiotics on inflammatory and metabolic indicators in patients with type 2 diabetes. By assessing the potential of probiotics to modify these markers, the study seeks to identify an economical and effective strategy for the prevention and treatment of type 2 diabetes.

Interventions

DIETARY_SUPPLEMENTProbiotics

Serum and fecal samples were collected at the beginning and end of the study to evaluate the effects of probiotic consumption on immune markers, metabolites, and gut microbiota before and after administration.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Signed an informed consent form before the study and has a thorough understanding of the content, process, and possible adverse reactions of the study; 2. Age 18 (inclusive) and above, gender not limited; 3. Diagnosed with type 2 diabetes mellitus; 4. Not diagnosed with cardiovascular, kidney, or any other diabetic complications.

Exclusion criteria

1. Age over 75 years old; 2. Use of exogenous insulin or patients with cardiovascular disease and other complications; 3. Patients who are currently using α-glucosidase inhibitors; 4. Patients who have a habit of taking probiotics or are currently taking probiotics; 5. Pregnant or lactating women; 6. Subjects deemed unsuitable for participation in this clinical study by the investigators due to other reasons.

Design outcomes

Primary

Measure	Time frame	Description
Inflammatory markers	12 weeks	Blood samples will be collected from patients with type 2 diabetes mellitus (T2DM), centrifuged to obtain serum, and analyzed for tumor necrosis factor-alpha (TNF-α), interleukins 6 (IL-6), 10 (IL-10), and 18 (IL-18), IL-1β, and interferon-gamma (IFN-γ) to assess the impact of probiotics on T2DM patients.

Countries

China

Contacts

Primary ContactKang Liu, Doctor

liukang@nsmc.edu.cn15808432375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026