Status:
COMPLETED
To Evaluate the Beneficial Effect of Probiotics on NAFLD Patients and the Role of Gut Microbiota Modulation
Lead Sponsor:
GenMont Biotech Incorporation
Collaborating Sponsors:
Fu Jen Catholic University Hospital
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
In this study, the improvement of the clinical status of early-stage non-alcoholic fatty liver disease (NAFLD) patients after the probiotic intervention will be assessed. And the mechanism of probioti...
Detailed Description
Uncontrolled NAFLD evolves in Non-Alcoholic SteatoHepatitis (NASH), cirrhosis and liver cancer. Early intervention to prevent the progression of illness of NAFLD is very important. From 2005 to 2018, ...
Eligibility Criteria
Inclusion
- Diagnosis of Nonalcoholic fatty liver disease (NALFD) by ultrasound.
- The range of Alanine aminotransferase (ALT) blood test is 60-300 U/L
Exclusion
- Alcoholic consumption (Female ≥ 10g/day or Male ≥ 20g/per)
- Patients with liver diseases, HBV(hepatitis B virus), HCV(hepatitis C virus), Primary Biliary Cholangitis.
- Autoimmune system disease
- Wilson's disease
- Hereditary hemochromatosis
- Patients with uncontrolled malignancy
- The subject had previously received weight reduction surgery
- Taking Antibiotics, probiotics, or any other drugs that affect NAFLD or glucose and lipid metabolism in past 2 months
- Pregnant or lactating female patients
- Patient who have severe allergy to soybeans or peanuts
Key Trial Info
Start Date :
July 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05402449
Start Date
July 14 2022
End Date
May 31 2024
Last Update
July 5 2024
Active Locations (1)
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1
Fu Jen Catholic University Hospital
New Taipei City, Taiwan