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
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
hazreen.abdul_majid@kcl.ac.uk |
Study information
Study design | Multicentre randomised prospective double-blinded, placebo controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 15/01/2008 |
Completion date | 30/09/2009 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 40 patients (as of 03/10/2008) |
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
- England
- United Kingdom
Study participating centre
Room 4.46, Franklin- Wilkin's Building
London
SE1 9NH
United Kingdom
SE1 9NH
United Kingdom
Sponsor information
King's College London (UK)
University/education
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
keith.brennan@kcl.ac.uk | |
Website | http://www.kcl.ac.uk/ |
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)
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |