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Clinical trial

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

ID
Name
probiotic and NAFLD
Description
this study aimed to evaluate the effectiveness of Probiotics supplementation (lactobacillus) on NAFLD fibrosis score.
Trial arms
Trial start
2021-09-12
Estimated PCD
2022-12-31
Trial end
2023-03-01
Status
Completed
Phase
Early phase I
Treatment
Control Test
Lacteol fort 10 billion which contains culture medium and lactobacillus LS as active ingredients
Arms:
probiotic group, standard treatment group
Other names:
standard treatment group
Size
50
Primary endpoint
non alcoholic fatty liver disease (NAFLD) fibrosis score
12 week of probiotic supplementation
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-10-10

1 organization

1 product

1 indication

Organization
Ain Shams University
Product
Control Test
Indication
NAFLD