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Probiotic Supplementation and Pancreatic β-Cell Function in Type 2 Diabetes

NCT05765292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-03-13

No results posted yet for this study

Summary

Probiotics have beneficial effect on obesity related disorders in animal models. Current understanding for the beneficial effects of probiotics in type 2 diabetes strictly relies on animal and clinical data, which mainly focus on their impact on insulin resistance, anthropometric parameters, glycemic control and markers of chronic systemic inflammation. From the other hand, there is a lack of evidence-based probiotic efficacy on pancreatic β-cell function in terms of type 2 diabetes and related metabolic disorders. In this double-blind single center randomized clinical trial, effect of alive multistrain probiotic vs. placebo on pancreatic β-cell function in type 2 diabetes patient will be assessed.

Conditions

Interventions

DIETARY_SUPPLEMENT

Probiotic

The multiprobiotic which contains of 14 alive probiotic strains of Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the pa

DIETARY_SUPPLEMENT

Placebo

Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day

Sponsors & Collaborators

  • Taras Shevchenko National University of Kyiv

    collaborator OTHER

  • Danylo Halytsky Lviv National Medical University

    collaborator OTHER

  • Kyiv City Clinical Endocrinology Center

    collaborator OTHER

  • Bogomolets National Medical University

    lead OTHER

Principal Investigators

  • Nazarii Kobyliak · Bogomolets National Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-11-30
Completion
2021-12-15

Countries

  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05765292 on ClinicalTrials.gov