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

Completed

• Conditions: non alcoholic hepatic steatosis (NASH); Non-alcoholic fatty liver disease; 10052547; 10019654; 10003216

• Registration Number: NL-OMON44842
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 81

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Effect op NAFLD/NASH:<br /><br>- Primary outcome is reducting in hepatic steatosis without worsening of<br /><br>fibrosis as determined by liverbiopsy (Bruntclassification) and liver MRI after<br /><br>6 months </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Changes in bacerial composition of small intestine, large intestine and liver<br /><br>- Changes in vascular function (normalized wall index en mean wall thickness as<br /><br>measured with 3T MRI of the carotid artery<br /><br>- Changes in inflammatory tone (plasma TMAO/betaine and TNFalfa/CD68 expression<br /><br>on monocyte and in subcutanous adipose tissue)</p><br>