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ISRCTN
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ISRCTN06446184
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ClinicalTrials.gov identifier
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Public title
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What happens to the bacteria in the gut in patients who are receiving tube feeding with additional carbohydrate
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Scientific title
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Comparing the colonic microbiota, faecal short chain fatty acids and immune status among patients receiving enteral feeding: the effect of additional fructo-oligosaccharides
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Acronym
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ETF (Enteral Tube Feeding)
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Serial number at source
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07/H0702/41
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Study hypothesis
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To investigate the effect of additional fructo-oligosaccharides (FOS) supplementation on the faecal microbiota, short-chain fatty acids (SCFA), faecal pH, immune status and faecal output in patients receiving enteral tube feeding (ETF) for two-weeks.
Please note that as of 03/10/2008 this record was updated to include an extension to the anticipated end date, and an increase to the target number of participants. The initial anticipated end date of this trial was 30/09/2008 and the initial target number of participants was 20.
As of 08/07/2009 this record was further updated to indicate that it is now multicentre, with one further centre in the UK, and the anticipated end date of this trial was thus extended from 30/06/2009 to 30/09/2009.
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Ethics approval
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Barking and Havering Local Research Ethics Committee gave approval on the 12th November 2007 (provisionally granted subject to minor amendments) (ref: 07/H0702/41). Full ethics approval granted on the 14th December 2007. Amendment approved 19th September 2008.
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Study design
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Multicentre randomised prospective double-blinded, placebo 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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Enteral tube feeding and fructo-oligosaccharides supplementation
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Participants - inclusion criteria
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1. Intensive care unit (ICU) patients
2. Adult patients (both male and female)
3. Exclusive ETF with fibre formula
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Participants - exclusion criteria
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1. Patients receiving lactulose
2. Patients with gastrointestinal disease or gastrointestinal surgery
3. Patients currently receiving chemotherapy or gastrointestinal radiation therapy
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Anticipated start date
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15/01/2008
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Anticipated end date
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30/09/2009
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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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40 patients (as of 03/10/2008)
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Interventions
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Twenty patients from the ICU who will be starting ETF with the routine fibre formula will be recruited. Ten patients will be randomly assigned to receive an additional 7 g of FOS per day while the other ten patients will receive 7 g of an identically packaged carbohydrate/maltodextrose (placebo) for 14 days. Giving the patient the additional 7 g of FOS or maltodextrose will start following the collection of first stool sample after enrolment to the ETF study.
Randomisation will be conducted using the EPISTAT program. The principal investigator will be kept blinded to whether the patient is receiving the additional 7 g of FOS or the additional 7 g of maltodextrose. A copy of the blinding code will be kept by the lead research nurse on ICU in the unlikely event that they need to unblind the study.
The 7 g of FOS or the identically packaged inactive carbohydrate will be dissolved in 50 ml of sterile water and flushed via the feeding tube daily by the nurse in charge. Water flushes to ETF patients are part of routine clinical care in the intensive care unit. The principal investigator will assist the nurse in charge in ensuring patients receive the correct additional carbohydrate and this will be monitored daily.
Stool samples will be collected by the principal investigator using normal routine stool sample collection procedures. Three faecal samples will be taken from each patient at baseline following starting ETF but prior to additional FOS (day 0), during additional FOS (day 6 - 8) and at the end of additional FOS (day 12 - 14).
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Primary outcome measure(s)
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Difference in the colonic microbiota (measured using fluorescent in-situ hybridisation).
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Secondary outcome measure(s)
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1. Incidence of diarrhoea (measured using King's Stool Chart)
2. Faecal samples will be analysed for:
2.1. SCFA concentrations
2.2. pH
2.3. C. difficile enterotoxin A/B
2.4. Faecal secretory Immunoglobulin A (IgA)
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Sources of funding
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1. King's College London (UK)
2. University of Malaya (Malaysia)
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Trial website
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Publications
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Contact name
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Mr
Hazreen
Abdul Majid
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Address
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Room 4.46, Franklin- Wilkin's Building
Waterloo Campus
School Of Biomedical and Health Sciences
King's College London
150 Stamford Street
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City/town
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London
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Zip/Postcode
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SE1 9NH
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Country
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United Kingdom
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Email
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hazreen.abdul_majid@kcl.ac.uk
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Sponsor
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King's College London (UK)
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Address
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c/o Keith Brennan
Room 1.8, Hodgkin Building, Guy's Campus
School of Biomedical and Health Sciences
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City/town
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London
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Zip/Postcode
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SE1 4UL
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Country
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United Kingdom
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Email
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keith.brennan@kcl.ac.uk
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Sponsor website:
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http://www.kcl.ac.uk/
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Date applied
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10/12/2007
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Last edited
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08/07/2009
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Date ISRCTN assigned
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18/01/2008
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