¡®Faecal microbiota transfusion for decolonization ofmultidrug resistant Enterobacteriaceae in renaltransplant recipients (RESET): a pilot study.¡¯
- Conditions
- multi drug resistance colonizationrenal transplant recipientsMDR infectionsfaecal microbiota transfusion
- Registration Number
- NL-OMON22882
- Lead Sponsor
- Department of Infectious Diseases and Medical Microbiology, Leiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following
criteria:
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from
participation in this study:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency and magnitude of any adverse events within 1 month of faecal microbiota<br>transfusion, including infections. The occurrence of renal transplant related adverse events<br>(graft loss, biopsy-proven acute rejection, doubling of serum creatinine) within 3 months after<br>FMT.
- Secondary Outcome Measures
Name Time Method Secondary / exploratory study parameters:<br /><br>- Number of participants with intestinal carriage of MDRE after FMT (assessed at 1 and 2<br>weeks and 1, 3 and 6 months after FMT).<br /><br>- Number of participants with one or more MDRE infection(s) within 6 months after FMT.<br /><br>- Change (relative to baseline) in the microbiota composition during 6 months of follow-up.<br /><br>- Change in microbiome diversity, calculated by Shannon diversity index, during 6 months of<br>follow-up.<br /><br>- Prevalence of antibiotic resistance genes in faecal samples during 6 months of follow up as<br>determined by metagenomics.<br /><br>- Magnitude of intra-patient variability in immunosuppressive drug exposure.