multi drug resistance colonization renal transplant recipients MDR infections faecal microbiota transfusion
Conditions
Interventions
Intervention:
Intervention group (6 subjects): Oral gut decontamination regimen colistin sulphate
(1.000.000 E 4¡Á/day) and neomycin sulphate (250 mg 4¡Á/day) for 5 days, combined with
nitrofurantoin
Sponsors
Department of Infectious Diseases and Medical Microbiology, Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Competent female renal transplant recipient aged 18 or above. 2. Intestinal carriage of extended-spectrum ¦Â-lactamase Enterobacteriaceae (ESBL-E) and/or carbapenemase producing Enterobacteriaceae (CPE) by rectal swab or stool culture tests (¡Ý2x). 3. A history of ¡Ý 1 documented infection by these bacteria <6 months before enrolment. 4. Adequate understanding of the procedures of the study and agrees to abide strictly thereby. 5. Ability to communicate well with the investigators and availability attend all study visits. 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Need for systemic antibiotics. 2. ICU admission at enrolment. 3. Creatinine clearance <30 ml/min. 4. (Planned) pregnancy during study. 5. Allergy / contraindication study drugs. 6. Recurrent aspirations / chronic dysphagia. 7. Recent intra-abdominal surgery. 8. A history of acute rejection within 6 months before enrolment. 9. Treatment with alemtuzumab within 6 months before enrolment. 10. Treatment with of eculizumab within 3 months before enrolment. 11. Clinical signs of active colitis / gastro-enteritis, including active infections (EBV /CMV / adenovirus / Clostridium difficile / chronic parasitic infection) or active inflammatory bowel disease. 12. Severe food allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and magnitude of any adverse events within 1 month of faecal microbiota transfusion, including infections. The occurrence of renal transplant related adverse events (graft loss, biopsy-proven acute rejection, doubling of serum creatinine) within 3 months after FMT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary / exploratory study parameters: - Number of participants with intestinal carriage of MDRE after FMT (assessed at 1 and 2 weeks and 1, 3 and 6 months after FMT). - Number of participants with one or more MDRE infection(s) within 6 months after FMT. - Change (relative to baseline) in the microbiota composition during 6 months of follow-up. - Change in microbiome diversity, calculated by Shannon diversity index, during 6 months of follow-up. - Prevalence of antibiotic resistance genes in faecal samples during 6 months of follow up as determined by metagenomics. - Magnitude of intra-patient variability in immunosuppressive drug exposure. | — |
Contacts
Public ContactI.N. Vlasveld
Outcome results
None listed