protocolSection identificationModule nctId: NCT06352697, orgStudyIdInfo id: DELI_MASLD, briefTitle: Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Adults MASLD Patients (DELI_MASLD Study), statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-08, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Bogomolets National Medical University, class: OTHER, collaborators name: Taras Shevchenko National University of Kyiv, collaborators name: Danylo Halytsky Lviv National Medical University, collaborators name: Kyiv City Clinical Endocrinology Center, collaborators name: Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine, collaborators name: MirImmunoFarm, collaborators name: Stellar Biotics, descriptionModule briefSummary: 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., conditionsModule conditions: Metabolic Dysfunction Associated Steatotic Liver Disease, conditions: Steatotic Liver Disease, conditions: Hepatic Steatosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: 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, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ACTUAL, armsInterventionsModule interventions name: Probiotic lysate (postbiotic and metabiotc), interventions name: Placebo, outcomesModule primaryOutcomes measure: changes in fatty liver index (FLI), primaryOutcomes measure: hepatic steatosis index (HSI), primaryOutcomes measure: TyG index, secondaryOutcomes measure: Concentration of AST, secondaryOutcomes measure: Concentration of ALT, secondaryOutcomes measure: Concentration of Gamma-glutamyl Transferase (GGT), secondaryOutcomes measure: Concentration of Total Cholesterol (TC), secondaryOutcomes measure: Concentration of Tryglicerides (TG), secondaryOutcomes measure: Concentration of LDL-Cholesterol (LDL-C), secondaryOutcomes measure: Concentration of VLDL-Cholesterol (VLDL-C), secondaryOutcomes measure: Concentration of HDL-Cholesterol (HDL-C), secondaryOutcomes measure: Concentration of high sensitivity CRP (hs-CRP), secondaryOutcomes measure: Concentration of IL-6, secondaryOutcomes measure: waist circumferences (WC), secondaryOutcomes measure: body mass index (BMI), secondaryOutcomes measure: visceral fat content, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bogomolets National Medical University, city: Kyiv, zip: 01601, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Kyiv City Clinical Endocrinology Center, city: Kyiv, zip: 01601, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Taras Shevchenko National University of Kyiv, city: Kyiv, zip: 01601, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine, city: Kyiv, zip: 02000, country: Ukraine, geoPoint lat: 50.45466, lon: 30.5238, locations facility: Danylo Halytsky Lviv National Medical University, city: Lviv, zip: 79010, country: Ukraine, geoPoint lat: 49.83826, lon: 24.02324, hasResults: False