Protocol for a double-blind placebo-controlled trial to evaluate the efficacy of probiotics in reducing antibiotics for infection in care home residents: the Probiotics to Reduce Infections iN CarE home reSidentS (PRINCESS) trial.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
20 06 2019
Historique:
entrez: 23 6 2019
pubmed: 23 6 2019
medline: 9 6 2020
Statut: epublish

Résumé

Care home residents are at increased risk of infections and antibiotic prescription. Reduced antibiotic use from fewer infections would improve quality of life. The PRINCESS is a double-blind, individually randomised, placebo-controlled trial that will assess the effect of a daily oral probiotic combination of Ethics approval is from the Wales Research Ethics Committee 3. Findings will be disseminated through peer-reviewed journals and conferences; results will be of interest to patient and policy stakeholders. ISRCTN16392920; Pre-results.

Identifiants

pubmed: 31227535
pii: bmjopen-2018-027513
doi: 10.1136/bmjopen-2018-027513
pmc: PMC6596947
doi:

Substances chimiques

Anti-Bacterial Agents 0

Banques de données

ISRCTN
['ISRCTN16392920']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e027513

Subventions

Organisme : Department of Health
ID : EME/13/95/10
Pays : United Kingdom
Organisme : Medical Research Council
Pays : United Kingdom

Informations de copyright

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: PCC reports grants from National Institute for Health Research, grants from EME Programme funded by NIHR / MRC. During the conduct of the study PCC receives personal fees from Christian Hansen, and non-financial support from Christian Hansen outside the submitted work.

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Auteurs

Eleri Owen-Jones (E)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Rachel Lowe (R)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Mark Lown (M)

Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.

David Gillespie (D)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Katy Addison (K)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Tony Bayer (T)

Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, UK.

Philip C Calder (PC)

Human Development & Health, Faculty of Medicine, University of Southampton, Southampton, UK.
NIHR Southampton Biomedical Research Centre, University of Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.

Jane Davies (J)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Mina Davoudianfar (M)

Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

James Downs (J)

Lay Representative, Cardiff, UK.

Alison Edwards (A)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Nick A Francis (NA)

Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, UK.

Richard Fuller (R)

Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.

Richard Hobbs (R)

Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

Kerenza Hood (K)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Mandy Lau (M)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Paul Little (P)

Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.

Michael Moore (M)

Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.

Victoria Shepherd (V)

Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, UK.

Helen Stanton (H)

Centre for Trials Research, Cardiff University, Cardiff, UK.

Alun Toghill (A)

Lay Representative, Cardiff, UK.

Mandy Wootton (M)

Specialist Antimicrobial Chemotherapy Unit, Public Health Wales Microbiology Cardiff, University Hospital of Wales, Cardiff, UK.

Chris C Butler (CC)

Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.

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