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

Launched by BOGOMOLETS NATIONAL MEDICAL UNIVERSITY · Mar 10, 2023

Keywords

ClinConnect Summary

In this single-center double blind, placebo controlled, parallel group study, type 2 diabetes patients from the Kyiv City Clinical Endocrinology Center will be selected. They will be randomly assigned to receive multiprobiotic "Symbiter" or placebo for 8-weeks administered as a sachet formulation in double-blind treatment. Randomization will be done by the study statistician based on a computer-generated list. The groups will be homogeneous according to age, sex and diagnostic criteria. The assignment of groups will be blind to participants, research staff and outcome assessors moreover, to...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • adult participants (aged 18 to 75);
• • presence of T2D diagnosis based on the criteria of the American Diabetes Association (plasma glucose in fasting state ≥7.0 mmol/l; plasma glucose at random measuring ≥11.1 mmol/l; HbA1c ≥6.5% or glucose \> 11.1 mmol/l 2 hours after tolerance test with 75 g of glucose);
• • presence of pancreatic β-cell dysfunction which defined as HOMA2-β\<50%;
• • treatment with insulin therapy alone or in combination with oral anti-diabetic drugs (metformin and/or sulphonylureas) in a stable dose for at least 3 months prior to randomization;
• • HbA1c level 6.5 to 11.0%;
• • signed informed consent
• Exclusion Criteria:
• • presence of T1D;
• • intake of anti-diabetic drugs except for those specified in the inclusion criteria (pioglitazone, glucagon-like peptide (GLP-1) analogs, dipeptide-peptidase 4 (DPP-4) inhibitors, etc.);
• • severe diabetes-related complications at screening (ie, end-stage diabetic kidney disease, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy);
• • regular intake of probiotics, prebiotics or antibiotics for 3 months prior the inclusion;
• • previously diagnosed allergy to probiotics;
• • gastrointestinal disorders including food allergy, gluten-sensitive enteropathy, ulcerative colitis;
• • an uncontrolled cardiovascular or respiratory disease, an active malignant tumor or chronic infections;
• • participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks prior to enrollment;
• • participation in another clinical trial;
• • pregnancy or lactation.