Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Type 2 Diabetes Patients (DELI_Diab Study)

Summary

The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes patients.

The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month.

Conditions

• Obesity
• Obesity, Abdominal
• Insulin Resistance
• Insulin Sensitivity
• Type2 Diabetes
• Type 2 Diabetes Mellitus in Obese

Interventions

DIETARY_SUPPLEMENT

Probiotic lysate (postbiotic and metabiotic)

Each capsule contains 100 mg of cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023 in powder

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

• Taras Shevchenko National University of Kyiv

  collaborator OTHER

• Danylo Halytsky Lviv National Medical University

  collaborator OTHER

• Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine

  collaborator OTHER

• Kyiv City Clinical Endocrinology Center

  collaborator OTHER

• MirImmunoFarm

  collaborator UNKNOWN

• Stellar Biotics

  collaborator UNKNOWN

• Bogomolets National Medical University

  lead OTHER

Principal Investigators

• Nazarii Kobyliak, PhD · 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

2023-02-01

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• Ukraine

Study Locations