Fatty Liver, Nonalcoholic
Conditions
Keywords
Probiotic
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
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotic-Lactobacillus Zeae and Lactobacillus reuteri
DIETARY_SUPPLEMENTPlacebo
placebo
Sponsors
Chiang Mai University
Thailand Institute of scientific and technological research
Phramongkutklao College of Medicine and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
probiotic vs placebo
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver stiffness by fibroscan | 12 weeks | Fibroscan- transient elastography in kilopascals (kPa) |
| Liver steatosis by fibroscan | 12 weeks | Shear wave velocity with controlled attenuation parameter (CAP) unit in decibels per meter (dB/m) |
| Liver steatosis by MRI | 12 weeks | Hepatic steatosis with MRI-PDFF (the percent ratio of the density of mobile protons from triglycerides and the total density of protons from mobile triglycerides and mobile water). Outcome Measures was report as percent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anthropomorphic evaluation: composition analysis | 12 weeks | Body fat in percentage |
| Anthropomorphic evaluation | 12 weeks | Body muscle in kilogram |
| Liver inflammation | 12 weeks | Evaluated alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), gamma-glutamyl transferase (GGT; U/L), and alkaline phosphatase (ALP; U/L) |
| Metabolic profile: HOMA IR | 12 weeks | Fasting plasma glucose and serum insulin level will be combined to report in HOMA IR in mg/dl x mIU/L |
| Metabolic profile: serum lipid profiles | 12 weeks | Total cholesterol in mg/dL, low-density lipoprotein (LDL) cholesterol in mg/dL, high-density lipoprotein (HDL) in mg/dl, cholesterol in mg/dL, and triglyceride in mg/dL |
| Metabolic profile | 12 weeks | Fasting plasma glucose (FPG) in mg/dL |
| Inflammatory marker | 12 weeks | hsCRP level in mg/L |
| Anthropomorphic evaluation: BMI | 12 weeks | Weight and height will be combined to report BMI in kg/m\^2 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal SCFA | 12 weeks | Fecal SCFA (acetate, propionate and butyrate) in microgram/ml metagenomic sequencing (Next-generation sequencing) |
Countries
Thailand
Outcome results
None listed