Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease

Launched by PHRAMONGKUTKLAO COLLEGE OF MEDICINE AND HOSPITAL · Jun 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a probiotic supplement can help treat patients with non-alcoholic fatty liver disease (NAFLD), a condition where fat builds up in the liver without alcohol being a factor. Participants will be randomly assigned to receive either the probiotic or a placebo (a sugar pill) without knowing which one they got. The goal is to see if the probiotic can improve liver health.

To join this study, participants need to be adults between 20 and 80 years old who have been diagnosed with NAFLD or non-alcoholic steatohepatitis (NASH). However, those who have recently used probiotics, certain medications, or have a history of significant alcohol consumption or other serious health conditions may not be eligible. If you decide to participate, you can expect regular check-ups to monitor your health and help researchers understand how the probiotic affects liver fat levels. This study is currently recruiting participants, so it’s a great opportunity to contribute to research that could improve treatments for this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria: 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 Criteria:
• • 1. Supplement with probiotic/prebiotic within 2 weeks
• • 2. Previous antibiotic/antifungus within 1 month
• • 3. 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
• • 4. 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
• • 5. Chronic liver diseases from other cause such as viral hepatitis, autoimmune hepatitis
• 6. 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
• • 7. Use of GLP-1 agonist therapy (for example, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide and albiglutide), vitamin E and pioglitazone
• • 8. Active autoimmune disease, including actively treated lupus, rheumatoid arthritis, inflammatory bowel disease
• • 9. Active malignancy on treatment
• • 10. New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \<30%
• • 11. Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections
• • 12. Respiratory compromised
• • 13. Severe renal impairment (eGFR \<30 ml/min/1.73 m2)
• • 14. Pregnancy