Status:
COMPLETED
Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease
Lead Sponsor:
Phramongkutklao College of Medicine and Hospital
Collaborating Sponsors:
Chiang Mai University
Thailand Institute of scientific and technological research
Conditions:
Fatty Liver, Nonalcoholic
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial
Detailed Description
Probiotic supplement versus placebo for the treatment of patients with non-alcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial by access liver biochemistry, MRI-PDFF, f...
Eligibility Criteria
Inclusion
- Male and female adults ≥20,\<80 years of age who suspected or confirmed diagnosis of NASH/NAFLD suggested by the historical data, they must meet one of the following criteria:
- Fatty liver by imaging then fibroScan with CAP ≥ 248 dB m Liver biopsy compatible with NASH/NAFLD
Exclusion
- Supplement with probiotic/prebiotic within 2 weeks
- Previous antibiotic/antifungus within 1 month
- History of significant alcohol consumption for a period of more than three consecutive months within 1 year before screening. Significant alcohol consumption is defined as equal to or greater than approximately two alcoholic drinks per day for males and approximately 1.5 alcoholic drinks per day for females
- Regular use of drugs historically associated with NAFLD, which include, but are not limited, to the following: amiodarone, methotrexate, systemic glucocorticoids at greater than 5 mg/d
- Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis
- Hepatic decompensation or impairment defined as presence of any of the following:
- History of esophageal varices, ascites or hepatic encephalopathy.
- Serum albumin \<3.5 g dl-1, except as explained by nonhepatic causes.
- INR \> 1.4
- Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone
- Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease
- Active malignancy on treatment
- New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \<30%
- Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections
- Respiratory compromised
- Severe renal impairment (eGFR \<30 ml/min/1.73 m2)
- Pregnancy
Key Trial Info
Start Date :
July 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06491342
Start Date
July 25 2024
End Date
May 28 2025
Last Update
July 25 2025
Active Locations (2)
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1
Division of gastroenterology and hepatology
Ratchathewi, Bangkok, Thailand, 10400
2
Chiangmai university
Chiang Mai, Thailand, 50200