Faecal microbiota transfusion for decolonization of multidrug resistant Enterobacteriaceae in renal transplant recipients (RESET): a pilot study.

Recruiting

Conditions: intestinal carriage of multidrug resistant bacteria (Enterobacteriaceae)
10004018
10046590

Registration Number: NL-OMON54672

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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: 1. Competent renal transplant recipient aged 18 or
above. 2. Intestinal carriage of extended-spectrum β-lactamase
Enterobacteriaceae (ESBL-E) and/or carbapenemase producing Enterobacteriaceae
(CPE) by rectal swab or stool culture tests (>=2x). 3. A history of >= 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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters:<br /><br>Frequency and magnitude of any adverse event within 1 month of faecal<br /><br>microbiota transfusion, including infections. The occurrence of renal<br /><br>transplant related adverse events (graft loss, biopsy-proven acute rejection,<br /><br>doubling of serum creatinine) within 3 months after FMT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary / exploratory study parameters:<br /><br>- Number of participants with intestinal carriage of MDRE after FMT (assessed<br /><br>at 1 and 2 weeks and 1, 3 and 6 months after FMT).<br /><br>- Number of participants with one or more MDRE infection(s) within 6 months<br /><br>after FMT.<br /><br>- Change (relative to baseline) in the microbiota composition during 6 months<br /><br>of follow-up.<br /><br>- Change in microbiome diversity, calculated by Shannon diversity index, during<br /><br>6 months of follow-up.<br /><br>- Prevalence of antibiotic resistance genes in faecal samples during 6 months<br /><br>of follow up as determined by metagenomics. </p><br>