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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54672

Enrollment

Registered

2017-11-27

Start date

2018-04-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intestinal carriage of multidrug resistant bacteria (Enterobacteriaceae)

Interventions

Oral gut decontamination regimen polymixin/neomycine 500.000 IE/125 mg 4dd2 for 5 days, combined with nitrofurantoin (100 mg 2×/day) for 5 days if MDRE bacteriuria is present, followed by bowel lava

Eligibility

Age

18 Years to 64 Years

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 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

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.

Design outcomes

Primary

Measure	Time frame
Primary study parameters: Frequency and magnitude of any adverse event 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.	—

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)