Clincosm LogoSign in Get a demo

Probiotic Supplementation IN NAFLD Patients

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT06074094
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
17.6
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

this study aimed to evaluate the effectiveness of Probiotics supplementation (lactobacillus) on NAFLD fibrosis score.

Condition or Disease Intervention/Treatment Phase
  • Drug: Control Test
 Phase 4

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) is a disease characterized by accumulation of fat (> 5% of the liver tissue), in the absence of alcohol abuse or other chronic liver diseases. NAFLD can cause liver inflammation and progress to non-alcoholic steatohepatitis (NASH), fibrosis, cirrhosis or hepatocellular carcinoma (HCC).

The global prevalence of NAFLD in adults is estimated to be approximately 25%.The prevalence of NAFLD increases with increasing body mass index. in 2012 Chalasani et al, reported that 67% of overweight and 94% of obese individuals have NAFLD.

There is a consensus regarding increasing worldwide prevalence of NAFLD and its impact on health, especially the progression to liver cirrhosis and hepatocellular carcinoma. Longitudinal studies of NAFLD have reported an increase in all-cause mortality, cardiovascular mortality, and liver-related mortality , NAFLD carries a large economic burden and therefore poor health-related quality of life.

Lifestyle changes (diet and exercise) are the major and first suggestions of the guidelines ,as regard pharmaceutical interventions, agents with potential benefit in NASH include thiazolidinediones (TZDs), statins although they are well recognized in the treatment of dyslipidemia, their use as a specific treatment for NAFLD is not well evidenced.

There is some data suggest that disruptions in the gut microbiome may play a role in the pathogenesis of NAFLD and progressions to NASH.

A probiotic is a live microbial culture or cultured dairy product, which plays an important role in health. Probiotics for the treatment of NAFLD are seemingly a promising treatment option. Relatively easy availability, low cost, and absence of serious side effects make probiotics a lucrative choice.

liver biopsy remains the gold standard for NAFLD diagnosis but it is impractical as a diagnostic tool because it is invasive and expensive.

NAFLD fibrosis score constructed from routine clinical and laboratory variables can accurately predict the presence or absence of advanced fibrosis in NAFLD.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Probiotic Supplementation on Non-alcoholic Fatty Liver Disease in Patients Attending Family Medicine Clinic in Ain Shams University Hospitals
Actual Study Start Date :
Sep 12, 2021
Actual Primary Completion Date :
Dec 31, 2022
Actual Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: probiotic group

Healthy lifestyle habits and standard diet was recommended for participants ,Probiotic supplementation (Lacteol fort 10 billion) which contains culture medium and lactobacillus LS as active ingredients was administered in the form of oral sachets once daily for 12 weeks.

Drug: Control Test
Lacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients
Other Names:
  • standard treatment group

    		•
    Active Comparator: standard treatment group

    Healthy lifestyle habits and standard diet was recommended for participants ,

    Drug: Control Test
    Lacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients
    Other Names:
  • standard treatment group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. non alcoholic fatty liver disease (NAFLD) fibrosis score [12 week of probiotic supplementation]

      NAFLD fibrosis score constructed from routine clinical and laboratory variables can accurately predict the presence or absence of advanced fibrosis in NAFLD This scoring system had an area under the ROC curve of 0.88 (95% CI 0.85-0.92). 2 cutoff points were selected to identify the presence (> 0.676) and absence (< -1.455) of significant fibrosis.

    Secondary Outcome Measures

    1. ALT , AST [12 week of probiotic supplementation]

      effect of probiotic on ALT and AST

    2. body mass index (BMI) [12 week of probiotic supplementation]

      effect of probiotic on body mass index (BMI)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age between18 and 60

    • BMI ≥ 25 kg/m2

    • Sonographic findings of NAFLD +/- elevated liver enzymes (not more than 2 folds increase).

    Exclusion Criteria:

    • ▪ Any evidence of chronic liver diseases including viral hepatitis (B and C), auto immune hepatitis.

    • History of alcohol drinking.

    • Chronic medication use (drugs that cause elevated liver enzymes, recent antibiotic use or paracetamol use in the last month)

    • Persistent elevation of liver enzymes for 3 months.

    • History of DM.

    • History of statin therapy for cardiovascular disease (CVD).

    • History of recent operation.

    • History of gastroenteritis or diarrhea in the last 2 week.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Cairo Egypt 11517

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT06074094
    Other Study ID Numbers:
    • probiotic and NAFLD
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Non-alcoholic Fatty Liver Disease

    Study Results

    No Results Posted as of Oct 10, 2023