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ISRCTN
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ISRCTN33188590
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ClinicalTrials.gov identifier
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Public title
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Dietary oligofructose in the prevention of antibiotic associated diarrhoea in elderly patients
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0544103828
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Study hypothesis
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The purpose of this study is to see if the incidence of antibiotic related diarrhoea in elderly patients can be reduced by increasing colonic bifidobacteria concentrations with the concomitant prescription of oligofructose. Patients for the study will be identified by asking the Medical and Department for the Elderly teams if they had admitted any suitable patients. A brief clinical and drug history would be taken.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Digestive System: Diarrhoea
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Participants - inclusion criteria
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250 volunteers >65 years old.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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16/06/2000
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Anticipated end date
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15/06/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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250
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Interventions
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The volunteers would then be randomly allocated to one of two groups.
Group A will take a placebo (10 g/day of sucrose powder) or group B 10 g/day of oligofructose. The trial powders will be administered by the ward nursing staff along with the volunteers' normal medication. Volunteers will take the trial powders for the length of time they are taking antibiotics and for a further 7 days after stopping antibiotics. Volunteers will be assessed continuously by recording on a stool form using a four point scale (1 hard, 2 lumpy, 3 mushy and 4 loose) and interdefecatory intervals. Both give an indication of intestinal transit rate. Recordings will be done by the patient or nursing staff as appropriate. The volunteers will be followed up for 7 days after stopping the oligofructose or placebo. The volunteer will have further stool samples sent to be analysed for the presence of Clostridium difficile toxin if they develop diarrhoea during the study. The study's end point is the occurrence of diarrhoea due to Clostridium difficile.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Cambridge Consortium - Addenbrooke's (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15709999
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Contact name
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Dr
Stephen
Lewis
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Address
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Box No 201A
Department of Gastroenterology
Addenbrooke's NHS Trust
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 (0)7669 008 863
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Email
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)207 307 2622
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Fax
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+44 (0)207 307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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06/01/2009
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Date ISRCTN assigned
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12/09/2003
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