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
Protocol serial number	07/H0702/41
Sponsor	King's College London (UK)
Funders	King's College London (UK), University of Malaya (Malaysia)

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

Primary study design	Interventional
Study design	Multicentre randomised prospective double-blinded, placebo controlled trial
Secondary study design	Randomised controlled trial
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
Study acronym	ETF (Enteral Tube Feeding)
Study objectives	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(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) studied	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
Primary outcome measure(s)	Difference in the colonic microbiota (measured using fluorescent in-situ hybridisation).
Key secondary outcome measure(s)	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)
Completion date	30/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Key inclusion criteria	1. Intensive care unit (ICU) patients 2. Adult patients (both male and female) 3. Exclusive ETF with fibre formula
Key exclusion criteria	1. Patients receiving lactulose 2. Patients with gastrointestinal disease or gastrointestinal surgery 3. Patients currently receiving chemotherapy or gastrointestinal radiation therapy
Date of first enrolment	15/01/2008
Date of final enrolment	30/09/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Room 4.46, Franklin- Wilkin's Building

London
SE1 9NH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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