Clinical trial NCT06491342: Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease
Official title: Probiotic Supplement Versus Placebo for the Treatment of Patients With Non-alcoholic Fatty Liver Disease, A Randomized, Double Blinded, Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fatty Liver, Nonalcoholic
Keywords: Probiotic
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
Collaborators: name: Thailand Institute of scientific and technological research
First posted: 2024-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: probiotic vs placebo
Primary purpose: TREATMENT

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, fibroscan and metabolic profile

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

Primary outcomes:
measure: Liver steatosis by MRI
timeFrame: 12 weeks
measure: Liver steatosis by fibroscan
timeFrame: 12 weeks
measure: Liver stiffness by fibroscan
timeFrame: 12 weeks
Secondary outcomes:
measure: Liver inflammation
timeFrame: 12 weeks
measure: Metabolic profile
timeFrame: 12 weeks
measure: Metabolic profile
timeFrame: 12 weeks
measure: Metabolic profile: HOMA IR
timeFrame: 12 weeks
measure: Metabolic profile: serum lipid profiles
timeFrame: 12 weeks
measure: Inflammatory marker
timeFrame: 12 weeks
measure: Inflammatory marker
timeFrame: 12 weeks
measure: Anthropomorphic evaluation: BMI
timeFrame: 12 weeks
measure: Anthropomorphic evaluation: composition analysis
timeFrame: 12 weeks
measure: Anthropomorphic evaluation
timeFrame: 12 weeks
Other outcomes:
measure: Fecal SCFA
timeFrame: 12 weeks
Locations:
city: Ratchathewi
country: Thailand
facility: Division of gastroenterology and hepatology
state: Bangkok
Study officials:
affiliation: phramongkutklao
name: Natchaporn Noppacroh
role: PRINCIPAL_INVESTIGATOR
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