Non alcoholic fatty liver disease, fatty liver NAFLD
Conditions
Interventions
Participants take the probiotics daily and avoid antibiotics within 2 hours postingestion.
Usual diets are maintained, avoiding other probiotic supplements. Follow-ups at Day
90 include repeat measur
Experimental Dietary Supplement,Placebo Comparator Dietary Supplement
Sponsors
phramongkutklao hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male and female adults between 20and 80 years of age 2. 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 equal or more than 248 dB m - Fatty liver by liver biopsy compatible with NASH/NAFLD
Exclusion criteria
Exclusion criteria: 1. Supplement with probiotic or prebiotic within 2 weeks 2. Previous antibiotic or antifungal 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 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 less than 3.5 g dl, except as explained by nonhepatic causes. - INR more than 1.4 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 less than 30% 11. Known immunocompromised status, HIV or who have recurrent or chronic systemic bacterial, fungal, viral or protozoal infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver steatosis by fibroscan 0,12 weeks decibels per meter,Liver steatosis 0, 12 weeks percent,Liver stiffness by fibroscan 0,12 weeks kilopascals | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver inflammation 0,12 weeks alanine aminotransferase (ALT; U/L), aspartate aminotransferase (AST; U/L), gamma-glutamyl transferase (GGT; U/L), and alkaline phosphatase (ALP; U/L),Fasting plasma glucose 0, 12 weeks] mg/dL,HbA1C 0,12weeks %,HOMA IR 0, 12 weeks mg/dl x mIU/L,serum lipid profiles 0, 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,hsCRP level 0, 12 weeks] mg/L,IL-6) 0, 12 weeks pg/mL,Anthropomorphic evaluation 0, 12 weeks composition analysis | — |
Countries
Thailand
Contacts
Public ContactNatchaporn Noppacroh
Phramongkutklao hospital
Outcome results
None listed