Carriage of vancomycin-resistant Enterococ vancomycin-resistant Enterococ carrier
Conditions
Interventions
Fecal microbiota transplantation: Bowel lavage, followed by administering feces
suspension (obtained from te Nationale Donor Feces Bank), via a duodenal tube.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adult patients (*18 years at date of inclusion) Ability to provide informed consent Documented intestinal carriage of VRE by stool culture One of the following: o Any malignancy with the exception of successfully treated basal cell cancer of the skin o Any hospital-acquired infection in the past 12 months o Any type of vascular disease including class I-II congestive heart failure, acute myocardial infarction, (un)stable angina pectoris, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, aortic aneurysmata, resistant hypertension (defined as blood pressure that remains above 140 mmHg systolic or 90 mmHg diastolic in spite of the concurrent use of 3 antihypertensive agents of a different class) o Chronic lung disease o Chronic kidney disease, defined as a decreased kidney function (estimated glomerular filtration rate (CKD-EPI) between 15 ml/min/1.73m2 and 60 ml/min/1.73m2) or kidney damage (including microalbuminuria) for three or more months o Chronic liver disease o Cerebrovascular disease including stroke, transient ischemic attack or subarachnoid haemorrhage o Any haematological disorder o Any auto-immune disease with the exception of inflammatory bowel disease o Diabetes mellitus (all types)
Exclusion criteria
Exclusion criteria: - Difficult / impossible follow-up - Pregnancy or planned pregnancy or breastfeeding - Allergy or other contraindication to colofort - Severe food allergy (anaphylaxis, urticaria) - Recurrent aspirations / chronic dysphagia or anatomic contraindication to the placement of a nasogastric tube - Congestive heart failure class III-IV - Estimated life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be intestinal carriage of VRE (absence/presence by stool culture of VRE) 6 months / 170 - 185 days after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint will be intestinal carriage of VRE (absence/presence by stool culture of VRE) 12 months / 355 - 375 days after intervention | — |
Countries
Netherlands
Outcome results
None listed