Modulation of gut function using Gut Specific Nutrients in the critically ill

ISRCTN	ISRCTN61157513
DOI	https://doi.org/10.1186/ISRCTN61157513
Protocol serial number	LREC/04/378
Sponsor	Scarborough and North East Yorkshire Healthcare NHS Trust (UK)
Funders	Scarborough and North East Yorkshire Healthcare NHS Trust (UK), The Combined Gastroenterology Research Fund (UK)

Submission date: 12/04/2009
Registration date: 30/04/2009
Last edited: 24/03/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Macfie
Scientific

Department of General Surgery
Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom

Study information

Primary study design	Interventional
Study design	Double-blind placebo-controlled randomised clinical trial
Secondary study design	Randomised controlled trial
Scientific title	Modulation of gut function using gut specific nutrients in the critically ill: a double blind, placebo controlled, randomised clinical trial
Study acronym	GSN study
Study objectives	The aim of this study is to determine whether or not the use of a cocktail of gut specific nutrients would enhance recovery of gut function and to assess if this is associated with other clinical benefits.
Ethics approval(s)	Scarborough Hospital Local Research Ethics Committee approved on the 1st March 2004 (ref: LREC/04/378)
Health condition(s) or problem(s) studied	Gut failure
Intervention	Enrolled patients were randomised to either a control group (receiving placebo) or a study group (receiving a gut specific nutrient cocktail of glutamine, multivitamins and antioxidants [Forceval], probiotics [Trevis] and the prebiotic oligofructose). Total duration of treatment/placebo = 1 month (30 days) Follow-up for both treatment and placebo arms = 3 months
Intervention type	Supplement
Primary outcome measure(s)	Time to the return of normal gut function, measured hourly from recruitment to return of gut function.
Key secondary outcome measure(s)	1. Episodes of feed intolerance, measured daily for duration of stay 2. Numerous nutritional parameters 3. Use of opiates, total quantity measured for duration of stay, day 30 and day 90 4. Fluid balance, measured daily for duration of stay 5. The need for surgery, measured daily for duration of stay, on day 30 and day 90 6. Duration of intravenous infusions, measured daily for duration of stay 7. Serial intestinal permeability, measured on recruitment, on day 30 and day 90 8. Serial Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, measured on recruitment, weekly during admission, on day 30 and day 90 9. Other single organ failures, measured daily for duration of stay, on day 30 and day 90 10. Occurrence of septic, non-septic, and feed-related complications, measured daily for duration of stay, as well as mortality (measured throughout the 90 day follow-up period) and length of ICU and hospital stay (measured on discharge from ICU/hospital) 11. Need for patient readmission, measured after discharge to day 90 12. Total number of general practitioner (GP) visits, measured after discharge to day 90 13. Anthropometric measurements, measured on recruitment, weekly during admission, on day 30 and day 90 14. Hospital anxiety and depression (HAD) scores, measured on recruitment and then on day 30 and day 90 15. Pain and fatigue scores, measured on recruitment, weekly during admission, on day 30 and day 90
Completion date	30/07/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	50
Key inclusion criteria	Critically ill patients (aged greater than or equal to 18 years, either sex) with inadequate gut function
Key exclusion criteria	1. Failure to obtain consent (or assent by the next-of-kin) 2. Known intolerance to one or more of the study preparations 3. Aged less than 18 years 4. Pregnancy 5. Patients who are strictly 'nil-by-mouth' and therefore unable to receive the study preparations or appropriate placebos
Date of first enrolment	01/03/2004
Date of final enrolment	30/07/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of General Surgery

Scarborough
YO12 6QL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/11/2010		Yes	No