Status:
UNKNOWN
The Effect of Probiotics on the Clinical Outcomes and Gut Microenvironment in Patients With Fatty Liver
Lead Sponsor:
Universiti Kebangsaan Malaysia Medical Centre
Collaborating Sponsors:
B-Crobes Laboratory Sdn. Bhd
Fibronostics Pte. Ltd
Conditions:
Non-Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Fatty liver has been associated with high risk of progression to inflammation of the liver, liver cirrhosis (hardening of the liver), and eventually can lead to liver cancer. So far, the treatment for...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is one of the common causes of chronic liver disease nowadays. NAFLD is considered as the hepatic manifestation of metabolic syndrome. In Malaysia, the preval...
Eligibility Criteria
Inclusion
- Age 18 and above 2. Diagnosis of NAFLD is confirmed by the presence of fatty liver detected by abdominal ultrasound and controlled attenuation parameter (CAP) score from FibroScan® of \>263 3. Raised ALT level (above upper limit of normal): \> 35IU/L for males and \> 25 IU/L for females
Exclusion
- Evidence of other chronic liver diseases (as determined by clinical and standard investigations) - e.g. Hepatitis B, C infections, autoimmune hepatic disorders.
- Evidence of acute disorders that affecting the liver - e.g. drug induced liver injury, non-Hepatitis B, C viral infection.
- Biliary disease.
- Liver cancer - primary hepatocellular carcinoma or liver metastasis.
- Evidence of liver cirrhosis.
- Alcohol intake \> 20g/day for males and \>10g/day for females.
- Use of steatogenic medications within the past one months - e.g. systemic steroids, methotrexate.
- History of bariatric surgery
- Intake of antibiotics and/or probiotic and proton pump inhibitor within one month before the start of the study or during the study period.
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04074889
Start Date
August 30 2019
End Date
December 1 2020
Last Update
September 4 2019
Active Locations (1)
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1
The University of Malaysia Medical Centre
Cheras, Kuala Lumpur, Malaysia, 56000