To determine the effect of probiotics (microbial food supplements) on acquisition rates and colonization prevalence of CC17 ARE in two wards where ARE-colonization is endemic.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: the difference in acquisition rate of intestinal
ARE-colonization between periods A and B.
Secondary outcome
Secondary endpoint: the difference in endemic prevalence of intestinal
ARE-colonization between periods A and B.
Background summary
During the last decade Enterococcus faecium has emerged in the University
Medical Centre Utrecht as a nosocomial pathogen with cumulating antimicrobial
resitance, a trend seen in hospitals worldwide. In the E. faecium population
structure, based upon MLST, epidemic and most invasive isolates cluster in
clonal complex-17 (CC17), characterized by ampicillin resistance. Besides the
risk of infection, intestinal colonization with CC17 E. faecium of hospitalized
patients forms a major threat for human health care as a reservoir of
horizontal transferable antibiotic resistance genes.
We hypothesize that probiotics, defined as microbial food supplements that
improve intestinal colonization resistance, will decrease incidence and
prevalence of gut colonization with CC17 ampicillin resistant E. faecium (ARE)
in hospitalized patients. As a result nosocomial infections, patient-to-patient
transmission and possibilities for horizontal transfer of antibiotic resistance
genes will reduce as well.
Study objective
To determine the effect of probiotics (microbial food supplements) on
acquisition rates and colonization prevalence of CC17 ARE in two wards where
ARE-colonization is endemic.
Study design
Prospective cohort study existing of two periods (Period A with no intervention
and period B with probiotics as intervention) executed in two wards in a
cross-over design.
Intervention
During period B probiotics are added to the diet of all admissions to the study
ward twice daily. During period A patients will not receive probiotics
Study burden and risks
ARE prevalence and acquisition rates will be determined upon surveillance
swabs. No extra burden will be added by this study. There are no risks
associated with participation. The probiotic product as in this study has been
used in another clinical trial and is considered to be safe.
heidelberglaan 100, Postbus 85500
3508 GA Utrecht
Nederland
heidelberglaan 100, Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
All admissions during the study periods on 2 wards with a high prevalence of intestinal ARE-colonization: the geriatric and gastroenterology/nephrology wards of the UMCU.
Exclusion criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL14948.041.06 |