A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol
<p>Abstract</p> <p>Background</p> <p>Antibiotic associated diarrhoea complicates 5–39% of courses of antibiotic treatment. Major risk factors are increased age and admission to hospital. Of particular importance is <it>C. difficile</it> associated diarrhoea...
Main Authors: | , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
BMC
2012-05-01
|
Series: | BMC Infectious Diseases |
Subjects: | |
Online Access: | http://www.biomedcentral.com/1471-2334/12/108 |
id |
doaj-5ab655e164254c2bb87b0090082eb2fb |
---|---|
record_format |
Article |
spelling |
doaj-5ab655e164254c2bb87b0090082eb2fb2020-11-25T03:24:50ZengBMCBMC Infectious Diseases1471-23342012-05-0112110810.1186/1471-2334-12-108A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocolAllen Stephen JWareham KathieBradley CarolineHarris WynDhar AnjanBrown HelgaFoden AlwynCheung WayGravenor Michael BPlummer SuePhillips Ceri JMack Dietrich<p>Abstract</p> <p>Background</p> <p>Antibiotic associated diarrhoea complicates 5–39% of courses of antibiotic treatment. Major risk factors are increased age and admission to hospital. Of particular importance is <it>C. difficile</it> associated diarrhoea which occurs in about 4% of antibiotic courses and may result in severe illness, death and high healthcare costs. The emergence of the more virulent 027 strain of <it>C. difficile</it> has further heightened concerns. Probiotics may prevent antibiotic associated diarrhoea by several mechanisms including colonization resistance through maintaining a healthy gut flora.</p> <p>Methods</p> <p>This study aims to test the hypothesis that administration of a probiotic comprising two strains of lactobacilli and two strains of bifidobacteria alongside antibiotic treatment prevents antibiotic associated diarrhoea. We have designed a prospective, parallel group trial where people aged 65 years or more admitted to hospital and receiving one or more antibiotics are randomly allocated to receive either one capsule of the probiotic or a matching placebo daily for 21 days. The primary outcomes are the frequency of antibiotic associated and <it>C. difficile</it> diarrhoea during 8–12 weeks follow-up. To directly inform routine clinical practice, we will recruit a sufficient number of patients to demonstrate a 50% reduction in the frequency of <it>C. difficile</it> diarrhoea with a power of 80%. To maximize the generalizability of our findings and in view of the well-established safety record of probiotics, we will recruit a broad range of medical and surgical in-patients from two different health regions within the UK.</p> <p>Discussion</p> <p>Antibiotic associated diarrhoea constitutes a significant health burden. In particular, current measures to prevent and control <it>C. difficile</it> diarrhoea are expensive and disrupt clinical care. This trial may have considerable significance for the prevention of antibiotic associated diarrhoea in hospitals.</p> <p>Trial registration</p> <p>International Standard Randomised Controlled Trial Number Register ISRCTN70017204.</p> http://www.biomedcentral.com/1471-2334/12/108ProbioticLactobacilliBifidobacteriaAntibioticAntibiotic associated diarrhoea<it>Clostridium difficile</it> diarrhoeaElderlyHospital in-patient |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Allen Stephen J Wareham Kathie Bradley Caroline Harris Wyn Dhar Anjan Brown Helga Foden Alwyn Cheung Way Gravenor Michael B Plummer Sue Phillips Ceri J Mack Dietrich |
spellingShingle |
Allen Stephen J Wareham Kathie Bradley Caroline Harris Wyn Dhar Anjan Brown Helga Foden Alwyn Cheung Way Gravenor Michael B Plummer Sue Phillips Ceri J Mack Dietrich A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol BMC Infectious Diseases Probiotic Lactobacilli Bifidobacteria Antibiotic Antibiotic associated diarrhoea <it>Clostridium difficile</it> diarrhoea Elderly Hospital in-patient |
author_facet |
Allen Stephen J Wareham Kathie Bradley Caroline Harris Wyn Dhar Anjan Brown Helga Foden Alwyn Cheung Way Gravenor Michael B Plummer Sue Phillips Ceri J Mack Dietrich |
author_sort |
Allen Stephen J |
title |
A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol |
title_short |
A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol |
title_full |
A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol |
title_fullStr |
A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol |
title_full_unstemmed |
A multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the PLACIDE study protocol |
title_sort |
multicentre randomised controlled trial evaluating lactobacilli and bifidobacteria in the prevention of antibiotic-associated diarrhoea in older people admitted to hospital: the placide study protocol |
publisher |
BMC |
series |
BMC Infectious Diseases |
issn |
1471-2334 |
publishDate |
2012-05-01 |
description |
<p>Abstract</p> <p>Background</p> <p>Antibiotic associated diarrhoea complicates 5–39% of courses of antibiotic treatment. Major risk factors are increased age and admission to hospital. Of particular importance is <it>C. difficile</it> associated diarrhoea which occurs in about 4% of antibiotic courses and may result in severe illness, death and high healthcare costs. The emergence of the more virulent 027 strain of <it>C. difficile</it> has further heightened concerns. Probiotics may prevent antibiotic associated diarrhoea by several mechanisms including colonization resistance through maintaining a healthy gut flora.</p> <p>Methods</p> <p>This study aims to test the hypothesis that administration of a probiotic comprising two strains of lactobacilli and two strains of bifidobacteria alongside antibiotic treatment prevents antibiotic associated diarrhoea. We have designed a prospective, parallel group trial where people aged 65 years or more admitted to hospital and receiving one or more antibiotics are randomly allocated to receive either one capsule of the probiotic or a matching placebo daily for 21 days. The primary outcomes are the frequency of antibiotic associated and <it>C. difficile</it> diarrhoea during 8–12 weeks follow-up. To directly inform routine clinical practice, we will recruit a sufficient number of patients to demonstrate a 50% reduction in the frequency of <it>C. difficile</it> diarrhoea with a power of 80%. To maximize the generalizability of our findings and in view of the well-established safety record of probiotics, we will recruit a broad range of medical and surgical in-patients from two different health regions within the UK.</p> <p>Discussion</p> <p>Antibiotic associated diarrhoea constitutes a significant health burden. In particular, current measures to prevent and control <it>C. difficile</it> diarrhoea are expensive and disrupt clinical care. This trial may have considerable significance for the prevention of antibiotic associated diarrhoea in hospitals.</p> <p>Trial registration</p> <p>International Standard Randomised Controlled Trial Number Register ISRCTN70017204.</p> |
topic |
Probiotic Lactobacilli Bifidobacteria Antibiotic Antibiotic associated diarrhoea <it>Clostridium difficile</it> diarrhoea Elderly Hospital in-patient |
url |
http://www.biomedcentral.com/1471-2334/12/108 |
work_keys_str_mv |
AT allenstephenj amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT warehamkathie amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT bradleycaroline amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT harriswyn amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT dharanjan amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT brownhelga amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT fodenalwyn amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT cheungway amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT gravenormichaelb amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT plummersue amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT phillipscerij amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT mackdietrich amulticentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT allenstephenj multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT warehamkathie multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT bradleycaroline multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT harriswyn multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT dharanjan multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT brownhelga multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT fodenalwyn multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT cheungway multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT gravenormichaelb multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT plummersue multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT phillipscerij multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol AT mackdietrich multicentrerandomisedcontrolledtrialevaluatinglactobacilliandbifidobacteriainthepreventionofantibioticassociateddiarrhoeainolderpeopleadmittedtohospitaltheplacidestudyprotocol |
_version_ |
1724599547008647168 |