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

NCT06352697 | Completed

• 1 other identifier: DELI_MASLD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Postbiotics; metabiotics; L. rhamnosus; L. delbrueckii; Metabolic Dysfunction Associated Steatotic Liver Disease; fatty liver index; hepatic steatosis index

Outcome Measures

Primary Outcomes (3)

• changes in fatty liver index (FLI)

  FLI = \[e 0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (ggt) + 0.053\*waist circumference - 15.745) / (1 + e 0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (ggt) + 0.053\*waist circumference - 15.745)\] × 100

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]

• hepatic steatosis index (HSI)

  HSI = 8 x ALT/AST + BMI(+ 2 if type 2 diabetes yes, + 2 if female)

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]

• TyG index

  TyG = ln \[Fasting triglyceride (mg / dl) x Fasting glucose (mg / dl)\] / 2

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]

Secondary Outcomes (13)

• Concentration of AST

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]

• Concentration of ALT

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]

• Concentration of Gamma-glutamyl Transferase (GGT)

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]

• Concentration of Total Cholesterol (TC)

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]

• Concentration of Tryglicerides (TG)

  at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline]

Study Arms (2)

Probiotic lysate (postbiotic and metabiotc) group

ACTIVE COMPARATOR

oral, 2 capsules per day (BID) for 3 month treatment

Dietary Supplement: Probiotic lysate (postbiotic and metabiotc)

Placebo group

PLACEBO COMPARATOR

placebo, oral, 2 capsules per day (BID) for 3 month treatment

Dietary Supplement: Placebo

Interventions

Probiotic lysate (postbiotic and metabiotc) DIETARY_SUPPLEMENT

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

Probiotic lysate (postbiotic and metabiotc) group

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult participants (ages 18-70)
• presence of MASLD according to \"A multisociety Delphi consensus statement", 2023;
• the diagnosis of fatty liver was based on the results of abdominal ultrasonography. Of 4 known criteria (hepato-renal echo contrast, liver brightness, deep attenuation, and vascular blurring), the participants were required to have hepato-renal contrast and liver brightness to be given a diagnosis of SLD
• fatty liver index (FLI) more than 60;
• BMI 25-39.9 kg/m2;
• aspartate transaminase (AST) and alanine transaminase (ALT) ≤3x upper limit of normal;
• written informed consent.

You may not qualify if:

• recent hepatitis, or positive screening test for hepatitis B (hepatitis B virus surface antigen) or hepatitis C (hepatitis C antibody);
• alcohol abuse (\>20 g/day (2 standard drinks) in women or \> 30 g/d (3 drinks) in men over a two-year period);
• drug-induced liver disease, Wilson\'s disease, hereditary deficiency of antitrypsin-1 and idiopathic hemochromatosis;
• history of decompensated liver disease including ascites, encephalopathy or variceal bleeding;
• regular use of an agents with gut microbiota modulation activity (antibiotic, pro-, pre-, post or synbiotics supplement etc.) within 3 months prior to enrollment;
• allergy on probiotics or their components;
• use of agents such as vitamin E, omega-3 fatty acids or medications with evidence for effects on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid);
• subjects with a history of bariatric surgery or significant weight loss (\> 5% body weight) or rapid weight loss (\> 1.6kg/week), within 6 months prior to enrollment;
• uncontrolled cardiovascular or respiratory disease, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, 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 other clinical trials;
• presence of pregnancy or lactation.

Sponsors & Collaborators

• Bogomolets National Medical University: lead
• Taras Shevchenko National University of Kyiv: collaborator
• Danylo Halytsky Lviv National Medical University: collaborator
• Kyiv City Clinical Endocrinology Center: collaborator
• Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine: collaborator
• MirImmunoFarm: collaborator
• Stellar Biotics: collaborator

Study Sites (5)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

Location

Kyiv City Clinical Endocrinology Center

Kyiv, 01601, Ukraine

Location

Taras Shevchenko National University of Kyiv

Kyiv, 01601, Ukraine

Location

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

Kyiv, 02000, Ukraine

Location

Danylo Halytsky Lviv National Medical University

Lviv, 79010, Ukraine

Location

MeSH Terms

Conditions

Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization was done by the study statistician based on a computer-generated list. The groups were homogeneous according to age, sex and diagnostic criteria. The assignment of groups was blind to participants, research staff and outcome assessors moreover, to maintain blind parallel study the statistician was not aware of the allocation of participants to intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Endocrinology Department

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: February 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (5)