| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN06446184 |
| Date ISRCTN assigned | 18/01/2008 |
| Local reference number(s) | 07/H0702/41 |
| Public title | What happens to the bacteria in the gut in patients who are receiving tube feeding with additional carbohydrate |
| 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) |
| Disease/condition/study domain | Enteral tube feeding and fructo-oligosaccharides supplementation |
| 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. |
| Design/methodology | This is a randomised, prospective, double-blinded, placebo controlled trial which will be conducted at a single site hospital. |
| Research ethics review | Ethics approval received from the Barking and Havering Local Research Ethics Committee on the 12th November 2007 (provisionally granted subject to minor amendments (ref: 07/H0702/41). Full ethics approval granted on the 14th December 2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Intensive care unit (ICU) patients
2. Adult patients (both male and female)
3. Exclusive ETF with fibre formula |
| Participants - exclusion criteria | 1. Patients receiving lactulose
2. Patients with gastrointestinal disease or gastrointestinal surgery
3. Patients currently receiving chemotherapy or gastrointestinal radiation therapy |
| Patient information material |
|
| Anticipated start date | 15/01/2008 |
| Anticipated end date | 30/09/2008 |
| Status of trial | Ongoing |
| Target number of participants | Target recruitment - twenty patients |
| Interventions | 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). |
| Primary outcome measure(s) | Difference in the colonic microbiota (measured using fluorescent in-situ hybridisation). |
| 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) |
| Sources of funding | 1. King's College London (UK)
2. University of Malaya (Malaysia)
|
| Sponsor name | 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
United Kingdom
SE1 4UL |
| Sponsor email | keith.brennan@kcl.ac.uk |
| Sponsor website | http://www.kcl.ac.uk/ |
| Contact name | Mr Hazreen Abdul Majid |
| 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
United Kingdom
SE1 9NH |
| Contact email | hazreen.abdul_majid@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN06446184 |
| Date last extracted from ISRCTN register | 17/04/2008 |
