What happens to the bacteria in the gut in patients who are receiving tube feeding with additional carbohydrate

ISRCTN ISRCTN06446184
DOI https://doi.org/10.1186/ISRCTN06446184
Secondary identifying numbers 07/H0702/41
Submission date
10/12/2007
Registration date
18/01/2008
Last edited
03/12/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Hazreen Abdul Majid
Scientific

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

Email hazreen.abdul_majid@kcl.ac.uk

Study information

Study designMulticentre randomised prospective double-blinded, placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleComparing the colonic microbiota, faecal short chain fatty acids and immune status among patients receiving enteral feeding: the effect of additional fructo-oligosaccharides
Study acronymETF (Enteral Tube Feeding)
Study objectivesTo 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(s)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.
Health condition(s) or problem(s) studiedEnteral tube feeding and fructo-oligosaccharides supplementation
InterventionTwenty 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 typeSupplement
Primary outcome measureDifference in the colonic microbiota (measured using fluorescent in-situ hybridisation).
Secondary outcome measures1. 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 study start date15/01/2008
Completion date30/09/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants40 patients (as of 03/10/2008)
Key inclusion criteria1. Intensive care unit (ICU) patients
2. Adult patients (both male and female)
3. Exclusive ETF with fibre formula
Key exclusion criteria1. Patients receiving lactulose
2. Patients with gastrointestinal disease or gastrointestinal surgery
3. Patients currently receiving chemotherapy or gastrointestinal radiation therapy
Date of first enrolment15/01/2008
Date of final enrolment30/09/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Room 4.46, Franklin- Wilkin's Building
London
SE1 9NH
United Kingdom

Sponsor information

King's College London (UK)
University/education

c/o Keith Brennan
Room 1.8, Hodgkin Building, Guy's Campus
School of Biomedical and Health Sciences
London
SE1 4UL
England
United Kingdom

Email keith.brennan@kcl.ac.uk
Website http://www.kcl.ac.uk/
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

University/education

King's College London (UK)

No information available

University of Malaya (Malaysia)
Government organisation / Universities (academic only)
Alternative name(s)
University of Malaya, University Malaya, Malayan University, UM
Location
Malaysia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2011 Yes No
Results article results 01/12/2014 Yes No