Contact information
Type
Scientific
Primary contact
Ms M.J.A. de Regt
ORCID ID
Contact details
University Medical Centre Utrecht (UMCU)
Department of Medical Microbiology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 2505006
m.deregt@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06-274
Study information
Scientific title
Acronym
PACE
Study hypothesis
Probiotics, defined as microbial food supplements that improve intestinal colonisation resistance, will decrease incidence and prevalence of gut colonisation with CC17 ampicillin-resistant enterococcus faecium (ARE) in hospitalised patients.
Ethics approval
The trial was approved by the Medical Ethical Commission (METC) of the University Medical Center Utrecht on the 6th March 2007 (ref: 06-274).
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.
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ampicillin-resistant Enterococcus faecium (ARE) infection
Intervention
The name of the probiotic product that is used in this trial is Ecologic® AAD, a multi-species probiotic powder, containing ten species (Bifidobacterium bifidum, Bifidobacterium lactis (2x), Enterococcus faecium, Lactobacillus acidophilus (2x), Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus salivarius) at 10^9 cfu/gr, which will be added to the diet of all admissions in study period B, the intervention period. Winclove Bio Industries BV has been producing multi-species probiotic powders for almost fifteen years. The lactic acid bacteria used are all commercially available in other products. All components are legally admitted as food additives or food components. The product that will be used in this study, Ecologic® AAD, is notified as dietary medical food for special medical purposes.
Probiotics are considered to be safe for the host. In the European workshop on the safety aspects of lactic acid bacteria used as probiotics in 1999, it was concluded that the available evidence does not indicate any health risk posed by ingestion of lactic acid bacteria. The long history of consumption, the available epidemiological data, clinical trials and acute toxicity studies all suggest that lactic acid bacteria, commonly occurring in fermented and dairy foods (green olives, sauer-kraut, yoghurt, cheese, etc.) and used in current probiotics (lactobacilli and bifidobacteria added to yoghurt, etc.), are safe. In addition antibiotic susceptibility testing ensures that the used lactic acid bacteria are unlikely to influence undesirable antibiotic gene transfer cascades in vivo and are not expected to cause any risk for human health with regard to antibiotic resistance. In contrast, we hypothesise that probiotics can reduce the spread of multi-resistant nosocomial pathogens like CC17 E. faecium by preventing intestinal colonisation and thereby will contribute to reducing occurrence of nosocomial infections and possibilities for horizontal transfer of resistance genes.
In the intervention period twice a day a sachet containing 5 gram of the probiotic powder has to be consumed, preferably on an empty stomach in de morning and before going to sleep. When oral antibiotics are used, probiotics should be given at least two hours before or after antibiotics. The nursing staff will dissolve the probiotic powder in lucid water and will sign a special form when the patient has taken the product. In the case of gastric and duodenal tubes the dissolved product can be given via the tube. The product will be given as soon as oral consent is given after admission to one of the study wards until discharge of the ward.
During the admission patients are screened for ARE colonisation by a perianal swab on admission, before discharge and twice weekly during admission. When a patient discharged from the ward, no further follow-up will take place.
Intervention type
Drug
Phase
Not Specified
Drug names
Probiotics
Primary outcome measure
The difference in acquisition rate of rectal ARE-colonisation between periods A and B. Acquisition of ARE-colonisation is defined as a patient that is not colonised on admission that acquires colonisation during admission. This is measured by a perianal swab within 48 hours after admission and within 72 hours before discharge. At the end of the study, the total acquisition rate of period A is compared with the total acquisition rate of period B to investigate if there is a difference. This analysis is performed for both separate wards.
Secondary outcome measures
The difference in prevalence of rectal ARE-colonisation between periods A and B. Twice weekly all patients are screened for ARE-colonisation. On these days the prevalence of ARE-colonisation can be determined. Because of natural fluctuations, these prevalences will differ per day. Therefore, at the end of the study the mean prevalence and the distribution of ARE-colonisation in period A will be compared with period B to investigate if there is a difference that can be explained by the use of the investigational product. This analysis is performed for both separate wards.
Overall trial start date
01/05/2007
Overall trial end date
01/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All admissions on two wards (gastroenterology/nephrology and geriatrics) of the University Medical Centre Utrecht, where ARE colonisation is endemic.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
640
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/05/2007
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (The Netherlands)
Sponsor details
Department of Medical Microbiology
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
European Union (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list