Plain English Summary
Background and study aims
Antibiotic-associated diarrhea (AAD) occurs in 2-25% of nursing home residents, which may lead to dehydration, malnutrition, severe complications and hospitalizations. Research shows that probiotics can be effective and safe in reducing AAD. However, probiotics are not routinely used in Dutch nursing homes. The objectives of this evaluation are to develop a procedure for the implementation of probiotics to prevent AAD in nursing homes, to evaluate effects on AAD occurrence, and to evaluate the implementation process of probiotics in daily care.
Who can participate?
Nursing home residents having used either amoxicillin/clavulanic acid or ciprofloxacin.
What does the study involve?
Records of residents in nursing homes where probiotics were given with antibiotics are used to investigate the effect of the probiotics on diarrhea and compared with records of residents who were not given probiotics.
What are the possible benefits and risks of participating?
None
Where is the study run from?
1. Louis Bolk Institute (Netherlands)
2. De Alblashof, Rivas Zorggroep (Netherlands)
3. Waalburcht, Rivas Zorggroep (Netherlands)
4. Waerthove, Rivas Zorggroep (Netherlands)
When is the study starting and how long is it expected to run for?
January 2018 to February 2019.
Who is funding the study?
Winclove Probiotics BV (Netherlands)
Who is the main contact?
Dr Herman van Wietmarschen
h.vanwietmarschen@louisbolk.nl
Trial website
http://www.louisbolk.org/nl/publicaties/publicatie/?pubID=3402
Contact information
Type
Public
Primary contact
Dr Herman van Wietmarschen
ORCID ID
https://orcid.org/0000-0003-2225-0337
Contact details
Louis Bolk Institute
Kosterijland 3-5
Bunnik
3981 AJ
Netherlands
0343523860
h.vanwietmarschen@louisbolk.nl
Type
Scientific
Additional contact
Dr Herman van Wietmarschen
ORCID ID
https://orcid.org/0000-0003-2225-0337
Contact details
Kosterijland 3-5
Bunnik
3981 AJ
Netherlands
0343523860
h.vanwietmarschen@louisbolk.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
2019-003 VG
Study information
Scientific title
Probiotics use for antibiotic-associated diarrhea: a pragmatic participatory evaluation in nursing homes
Acronym
prOud
Study hypothesis
Does the implementation of probiotics in nursing homes result in a reduction of antibiotics-associated diarrhea?
Ethics approval
Medisch ethische toetsingscommissie Brabant (Medical ethical comittee Brabant). On 25 October 2017, a statement was received from the Ethical Committee in Brabant the Netherlands (no. 2017-56), that this evaluation did not involve experiments with patients or study subjects according to the Dutch Medical Research in Human Subjects Act (WMO) and didn’t require further ethics approval. The institutional review board and the client council of the Rivas Zorggroep approved the implementation and evaluation of probiotics.
Study design
Retrospective evaluation
Primary study design
Observational
Secondary study design
Epidemiological study
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Antibiotics-associated diarrhea
Intervention
Data on the occurence (yes/no) of antibiotics-associated diarrhea is collected from residents taking either amoxicillin/clavulanic acid or ciprofloxacin.
In three nursing home departments, probiotics were administered together with the antibiotics. Data from these departments is compared with historical data from residents not taking probiotics from the same departments up to 27 months in the past. The elderly care physician extracted data on stool changes from the medical records and judged whether AAD occurred in each of the episodes of antibiotics use. The frequencies of AAD in the sample of residents without probiotics were compared with the sample of residents with probiotics.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Incidence Antibiotics-associated diarrhea in the preceding 27 months, measured using patient records
Secondary outcome measures
None
Overall trial start date
01/09/2017
Overall trial end date
27/02/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Residents having used either amoxicillin/clavulanic acid or ciprofloxacin
Participant type
All
Age group
Other
Gender
Both
Target number of participants
40 residents using probiotics and 40 control residents.
Participant exclusion criteria
1. Not being able to swallow the probiotics
2. Not giving informed consent for using data
Recruitment start date
01/01/2018
Recruitment end date
31/08/2018
Locations
Countries of recruitment
Netherlands
Trial participating centre
De Alblashof, Rivas Zorggroep
De Alblashof 1A
Alblasserdam
2951 XR
Netherlands
Trial participating centre
Waalburcht, Rivas Zorggroep
Kleine Waal 6
Papendrecht
3353 BT
Netherlands
Trial participating centre
Waerthove, Rivas Zorggroep
Kerkbuurt 200
Sliedrecht
3361 BM
Netherlands
Sponsor information
Organisation
Louis Bolk Instituut
Sponsor details
Kosterijland 3-5
Bunnik
3981 AJ
Netherlands
+31 (0)343523860
info@louisbolk.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Winclove Probiotics BV
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study results will be disseminated in a report on the website of the research institute Louis Bolk Institute. A scientific publication will be written as well.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. (Dr. H.A> van Wietmarschen, h.vanwietmarschen@louisbolk.nl, anonimised raw data, data is available after completion and publication of the study, data is available for 5 years after completion of the study, raw data will be published as supplementary material with the publication, the publication of the data will be in an open access journal, participants gave informed consent to use the data anonymised for 5 years).
Intention to publish date
19/02/2020
Participant level data
Available on request
Basic results (scientific)
Publication list