Probiotic supplement for treating non-alcoholic fatty liver disease

Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease, A Randomized, Double Blinded, Placebo-controlled Clinical Trial

This study is testing whether a probiotic supplement can help people with non-alcoholic fatty liver disease feel better compared to a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 20 Years to 80 Years
• Sex: All
• Sponsor: Phramongkutklao College of Medicine and Hospital (other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Ratchathewi, Bangkok)
• Trial ID: NCT06491342 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a probiotic supplement compared to a placebo in treating patients diagnosed with non-alcoholic fatty liver disease (NAFLD). It employs a randomized, double-blind, placebo-controlled design to ensure unbiased results. Participants will undergo assessments including liver biochemistry, MRI-PDFF, fibroscan, and metabolic profiling to measure the impact of the probiotic on liver health. The study aims to provide insights into the potential therapeutic role of probiotics in managing NAFLD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 to 80 with a suspected or confirmed diagnosis of non-alcoholic steatohepatitis (NASH) or NAFLD.

Not a fit: Patients with significant alcohol consumption, chronic liver diseases from other causes, or those recently using probiotics or antibiotics may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a novel dietary intervention for patients with non-alcoholic fatty liver disease, potentially improving liver health and metabolic outcomes.

How similar studies have performed: Other studies have explored the use of probiotics for liver health, showing promising results, but this specific approach remains relatively novel.

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

Where this trial is running

Ratchathewi, Bangkok

• Division of gastroenterology and hepatology — Ratchathewi, Bangkok, Thailand (RECRUITING)

Study contacts

• Principal investigator: Natchaporn Noppacroh — phramongkutklao
• Study coordinator: Natchaporn Noppacroh, MD

Conditions: Fatty Liver, Nonalcoholic, Probiotic