Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults NAFLD Patients (DELI_NAFLD Study)

NCT05804422 | Completed

• 1 other identifier: DELI_NAFLD
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 4

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 MRI-PDFF and ultrasonography, liver stiffness (LS) measured by Shear Wave Elastography (SWE) and anthropomorphic variables in NAFLD 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

Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; Hepatic Steatosis; Fatty Liver

Keywords

Postbiotics; metabiotics; L. rhamnosus; L. delbrueckii; Obesity; Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (2)

• changes in hepatic fat content

  will be measured by magnetic resonance proton density fat fraction (MRI-PDFF) in %

  at 3 month (end of treatment)

• changes in hepatic fat content

  will be measured by ultrasound attenuation coefficient measurement (ACM) in dB/cm

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

Secondary Outcomes (6)

• liver stiffness (LS)

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

• hs-CRP

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

• waist circumferences (WC)

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

• body mass index (BMI)

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

• body fat in percentage

  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

Also known as: Del-Immune V® Extra

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 NAFLD diagnosed according to the recommendations of the American Gastroenterology Association (AGA) and American Association for the Study of Liver Disease (AASLD);
• 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 NAFLD
• MRI-PDFF of at least 6.4%;
• 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 (4)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

Location

Kyiv City Clinical Endocrinology Center

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

Non-alcoholic Fatty Liver Disease; Fatty Liver; Obesity

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nazarii Kobyliak, PhD

  Bogomolets National Medical University

  PRINCIPAL INVESTIGATOR

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: Associate Professor, Endocrinology Department

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 7, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

UA (4)