Feasibility analysis of nasoduodenal feces administration to eradicate resistant enterobacteriaeceae.

Completed

Conditions: nierfalen waarvoor niertransplantatie
ESBL urinary tract infections and ESBL colonisation
10004018
10038430

Registration Number: NL-OMON38475

Lead Sponsor: Academisch medisch centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Renal transplant recipients colonised by ESBL producing Entrobacteriaceae in the large intestine.
Stable renal allograft function with maintenance dose of immunosuppressive therapy.
No food allergies.

Exclusion Criteria

1: Patients with ESBL strain in urine which is resistant to first line antibiotics (as nitrofurantoin)
2: Patients still being ESBL positive in throat or urine despite pre-treatment with chlorhexidin or first line antibiotic (as nitrofurantoin).
3: Experiencing rejection episode which require high dose immune-suppressants or critically ill recipients admitted to the ICU.
4: Signs of diminished bowel passage or ileus
5: Recent endoscopy with biopsies within last three months
6: Pregnancy
7: Known food allergie to any kind of food products.
8: Heavily immunocompromised patients ( prednisone use of > 60 mg per day or CD4 count < 200 cells/L) or patients who require chemotherapy for active malignancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome is ESBL decolonisation of the rectum after 12 weeks post donor<br /><br>feces infusion. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1: Development of ESBL related urinary tract infection within 24 weeks<br /><br>follow-up time after donor feces infusion.<br /><br>2: Changes in microbiome prior and after donor feces infusion.</p><br>