FAME study: Fecal Administration for eradication of Multiresistant ESBL producing bacteria in carriers
Completed
- Conditions
- carriage of multiresistent bacteriaESBL carriage10002252
- Registration Number
- NL-OMON41318
- 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
ESBL carriage demonstrated in stool, rectum, perineum or urine
able to give informed consent
Life expectancy of three months or more
Exclusion Criteria
1. (Expected) prolonged compromised immunity due to high dose prednisolone, recent cytotoxic chemotherapy for a malignancy, or HIV infection with a CD4 count < 350 cells/L
2. Ileus or signs of diminished bowel passage, or altered anatomical situation which prohibits normal passage of a donor feces infusion
3. Admission to intensive care or vasopressive dependency at time of inclusion
4. Known food allergy to peanuts, wheat, tree nuts, shellfish, fish, milk, sesame, chickpeas or eggs, or other dietary factors that could be accidentally infused with a donor feces infusion.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The outcome and primary study parameter of the study is eradication of ESBL,<br /><br>from feces, urine and rectum.<br /><br>This wil be measured on four days following infusion, and subsequently one,<br /><br>two, four and 12 weeks following donor feces infusion.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome is antibioc use in the 12 weeks following infusion, the<br /><br>total amount of infections in the follow up period of twelve weeks and the<br /><br>composition of the intestinal flora.</p><br>