Probiotic Supplementation IN NAFLD Patients

NAFLD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06074094
• Other study ID #: probiotic and NAFLD
• Status: Completed
• Phase: Phase 4
• Start date: September 12, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: June 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• NAFLD
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Control Test
Lacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non alcoholic fatty liver disease (NAFLD) fibrosis score	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.	12 week of probiotic supplementation
Secondary	ALT , AST	effect of probiotic on ALT and AST	12 week of probiotic supplementation
Secondary	body mass index (BMI)	effect of probiotic on body mass index (BMI)	12 week of probiotic supplementation

External Links

•   Related Info
•   Related Info