Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/12/2007
Date assigned
18/01/2008
Last edited
03/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.kcl.ac.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes