Fecal Microbiota Transplantation for eradication of Vancomycin-resistant Enterococci (FAVOR): a pilot study

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

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

- 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 < 6 months
- Current hospitalization in an Intensive Care Unit
- Treatment with any systemic antibiotic on the day of inclusion
- Severe immunodeficiency
o Systemic chemotherapy * 30 days from baseline or planned chemotherapy within the next 12 months
o Human Immunodeficiency Virus (HIV) with CD4 count < 250/mcl
o Neutropenia with an absolute neutrophil count <1000/µL
o Hematopoietic stem cell transplant recipients
o Solid organ transplant recipients
- Inflammatory Bowel Disease (Crohn*s disease, Colitis Ulcerosa)
- Estimated glomerular filtration rate (CKD-EPI) < 15 ml/min/1.73m2
- Unavailability of compatible FMT preparation (with regard to donor / recipient CMV and EBV serology)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be intestinal carriage of VRE (absence/presence by<br /><br>stool culture of VRE) 6 months / 170 - 185 days after intervention</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoint will be intestinal carriage of VRE (absence/presence by<br /><br>stool culture of VRE) 12 months / 355 - 375 days after intervention</p><br>

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