Condition category
Digestive System
Date applied
03/02/2020
Date assigned
03/02/2020
Last edited
03/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://www.louisbolk.nl

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

Publication citations

Additional files

Editorial Notes

03/02/2020: Trial’s existence confirmed by Medisch ethische toetsingscommissie Brabant (Medical ethical comittee Brabant).