Contact information
Type
Scientific
Primary contact
Mr Hazreen Abdul Majid
ORCID ID
Contact details
Room 4.46
Franklin- Wilkin's Building
Waterloo Campus
School Of Biomedical and Health Sciences
King's College London
150 Stamford Street
London
SE1 9NH
United Kingdom
hazreen.abdul_majid@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
07/H0702/41
Study information
Scientific title
Comparing the colonic microbiota, faecal short chain fatty acids and immune status among patients receiving enteral feeding: the effect of additional fructo-oligosaccharides
Acronym
ETF (Enteral Tube Feeding)
Study hypothesis
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.
Ethics approval
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.
Study design
Multicentre randomised prospective double-blinded, placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Enteral tube feeding and fructo-oligosaccharides supplementation
Intervention
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).
Intervention type
Supplement
Phase
Not Applicable
Drug names
Fructo-oligosaccharides (FOS) supplementation
Primary outcome measures
Difference in the colonic microbiota (measured using fluorescent in-situ hybridisation).
Secondary outcome measures
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)
Overall trial start date
15/01/2008
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Intensive care unit (ICU) patients
2. Adult patients (both male and female)
3. Exclusive ETF with fibre formula
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 patients (as of 03/10/2008)
Participant exclusion criteria
1. Patients receiving lactulose
2. Patients with gastrointestinal disease or gastrointestinal surgery
3. Patients currently receiving chemotherapy or gastrointestinal radiation therapy
Recruitment start date
15/01/2008
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Room 4.46, Franklin- Wilkin's Building
London
SE1 9NH
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
c/o Keith Brennan
Room 1.8
Hodgkin Building
Guy's Campus
School of Biomedical and Health Sciences
London
SE1 4UL
United Kingdom
keith.brennan@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
King's College London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
University of Malaya (Malaysia)
Alternative name(s)
University of Malaya, UM
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Malaysia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21414042
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/24290345
Publication citations
-
Results
Majid HA, Emery PW, Whelan K, Faecal microbiota and short-chain fatty acids in patients receiving enteral nutrition with standard or fructo-oligosaccharides and fibre-enriched formulas., J Hum Nutr Diet, 2011, 24, 3, 260-268, doi: 10.1111/j.1365-277X.2011.01154.x.
-
Results
Majid HA, Cole J, Emery PW, Whelan K, Additional oligofructose/inulin does not increase faecal bifidobacteria in critically ill patients receiving enteral nutrition: A randomised controlled trial., Clin Nutr, 2013, doi: 10.1016/j.clnu.2013.11.008.