Evaluation of probiotics use for antibiotic-associated diarrhea in nursing homes
| ISRCTN | ISRCTN94786163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94786163 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2019-003 VG |
| Sponsor | Louis Bolk Instituut |
| Funder | Winclove Probiotics BV |
- Submission date
- 03/02/2020
- Registration date
- 03/02/2020
- Last edited
- 28/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Public
Louis Bolk Institute
Kosterijland 3-5
Bunnik
3981 AJ
Netherlands
 ORCID ID |
0000-0003-2225-0337 |
|---|---|
| Phone | 0343523860 |
| h.vanwietmarschen@louisbolk.nl |
Scientific
Kosterijland 3-5
Bunnik
3981 AJ
Netherlands
| ORCID ID |
0000-0003-2225-0337 |
|---|---|
| Phone | 0343523860 |
| h.vanwietmarschen@louisbolk.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective evaluation |
| Secondary study design | Epidemiological study |
| Study type | Participant information sheet |
| Scientific title | Probiotics use for antibiotic-associated diarrhea: a pragmatic participatory evaluation in nursing homes |
| Study acronym | prOud |
| Study objectives | Does the implementation of probiotics in nursing homes result in a reduction of antibiotics-associated diarrhea? |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Incidence Antibiotics-associated diarrhea in the preceding 27 months, measured using patient records |
| Key secondary outcome measure(s) |
None |
| Completion date | 27/02/2019 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 93 |
| Key inclusion criteria | Residents having used either amoxicillin/clavulanic acid or ciprofloxacin |
| Key exclusion criteria | 1. Not being able to swallow the probiotics 2. Not giving informed consent for using data |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 31/08/2018 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Alblasserdam
2951 XR
Netherlands
Papendrecht
3353 BT
Netherlands
Sliedrecht
3361 BM
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/05/2020 | 15/05/2020 | Yes | No |
| Dataset | 13/05/2020 | 28/03/2023 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/03/2023: Dataset and total final enrolment added.
15/05/2020: Publication reference added.
03/02/2020: Trial’s existence confirmed by Medisch ethische toetsingscommissie Brabant (Medical ethical comittee Brabant).
