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Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study)
Sponsor: Bogomolets National Medical University
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
Conditions
Interventions
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
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