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COMPLETED
NCT06352697
NA

Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study)

Sponsor: Bogomolets National Medical University

View on ClinicalTrials.gov

Summary

The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics on hepatic fat content as measured by biochemichal hepatic steatosis indeces, serum lipid profile, transaminases activity and chronic systemic inflammatory markers in MASLD 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.

Official title: Efficacy and Safety of Probiotic Lysate (Postbiotic and Metabiotic) Supplementation in Adults MASLD Patients

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2024-05-01

Completion Date

2025-01-31

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Probiotic lysate (postbiotic and metabiotc)

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

Locations (5)

Bogomolets National Medical University

Kyiv, Ukraine

Kyiv City Clinical Endocrinology Center

Kyiv, Ukraine

Taras Shevchenko National University of Kyiv

Kyiv, Ukraine

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

Kyiv, Ukraine

Danylo Halytsky Lviv National Medical University

Lviv, Ukraine