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

NCT06352697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-09

No results posted yet for this study

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.

Conditions

  • Metabolic Dysfunction Associated Steatotic Liver Disease
  • Steatotic Liver Disease
  • Hepatic Steatosis

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

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

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

    collaborator OTHER

  • MirImmunoFarm

    collaborator UNKNOWN

  • Stellar Biotics

    collaborator UNKNOWN

  • Bogomolets National Medical University

    lead OTHER

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

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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 NCT06352697 on ClinicalTrials.gov