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OpenTrials
Completed

NCT Number: NCT06074094

Probiotic Supplementation IN NAFLD Patients

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Test

Drug

Lacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients

Other names: standard treatment group

Primary outcomes

  1. non alcoholic fatty liver disease (NAFLD) fibrosis score

    Time frame: 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 outcomes

  1. ALT , AST

    Time frame: 12 week of probiotic supplementation

    effect of probiotic on ALT and AST

  2. body mass index (BMI)

    Time frame: 12 week of probiotic supplementation

    effect of probiotic on body mass index (BMI)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Probiotic Supplementation on Non-alcoholic Fatty Liver Disease in Patients Attending Family Medicine Clinic in Ain Shams University Hospitals

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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