Clinical trial NCT06074094: Probiotic Supplementation IN NAFLD Patients
Official title: Effect of Probiotic Supplementation on Non-alcoholic Fatty Liver Disease in Patients Attending Family Medicine Clinic in Ain Shams University Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: NAFLD
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: non alcoholic fatty liver disease (NAFLD) fibrosis score
timeFrame: 12 week of probiotic supplementation
Secondary outcomes:
measure: ALT , AST
timeFrame: 12 week of probiotic supplementation
measure: body mass index (BMI)
timeFrame: 12 week of probiotic supplementation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: