Effect of Multiple healthy donor intestinal microbiota infusions on non Alcoholic Steatosis Hepatis (NASH) and vascular function in obese subjects - MASH study

Academisch Medisch Centrum0 个研究点目标入组 81 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

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•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 < 60 ml/min)
•- Fasting glucose > 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.

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