non alcoholic hepatic steatosis (NASH) Non-alcoholic fatty liver disease
Conditions
Interventions
Patients will be treated with infusion of either allogenic or autologous
microbial transplantion by duodenal tube after bowel lavage.
Fecal transplantation therapy (week 0, 8 and 16 weeks) consists
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Recipients: - Caucasian - Male or postmenopausal female - Aged 21-69 years - Scheduled for liver biopsy on clinical indication (suspicion of NASH) - No concomitant medication;Donors - Male / postmenopausal female - Lean (BMI 20-25 kg/m2) - Aged 21-69 years - No concomittant medication
Exclusion criteria
Exclusion criteria: Recipients: - Cardiovascular disease - Cholecystectomy - Use of any concomittant medication including PPI , oral anticonceptivesand antibiotics in the past three months - Plasma ALAT / ASAT > 2.5 times the upper limit of normal - Other causes of liver disease besides NAFLD/NASH (e.g. hemachromatosis, auto-immune hepatitis, viral hepatitis, alcoholic steatohepatitis). - History of heavy alcohol use (>12 to 15 gram / day). - Renal disease (creatinin clearance 13.3 mmol/l - History of anaphylaxis, known allergy for gadolinium of other contrast agents, or other contra-indication for the use of gadolinium;Donors: - Diarrhea - Cholecystectomy - Unsafe sex practice - Any medication use including PPI, oral anticonceptives and antibiotics in the past three months - Serological presence of HIV, hepatitis A, B and/or C, active cytomegalovirus (CMV), active Eppstein-Barr virus (EBV), lues, amoebiasis or strongyloides - Presence of fecal bacterial pathogens (Salmonella, Shigella, Campylobacter, Yersinia, enteropathogenic E. coli), transmittable viruses (Rotavirus, Norovirus, enterovirus, parechovirus, sapovirus, adenovirus 40/41/52, astrovirus) or parasites - Positive C. difficile stool test - Individuals with an increased risk for one of the above conditions (e.g. homosexual contacts, recent blood transfusions) will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect op NAFLD/NASH: - Primary outcome is reducting in hepatic steatosis without worsening of fibrosis as determined by liverbiopsy (Bruntclassification) and liver MRI after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Changes in bacerial composition of small intestine, large intestine and liver - Changes in vascular function (normalized wall index en mean wall thickness as measured with 3T MRI of the carotid artery - Changes in inflammatory tone (plasma TMAO/betaine and TNFalfa/CD68 expression on monocyte and in subcutanous adipose tissue) | — |
Countries
Netherlands
Outcome results
None listed