Condition category
Digestive System
Date applied
12/04/2009
Date assigned
30/04/2009
Last edited
24/03/2011
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

Prof John Macfie

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LREC/04/378

Study information

Scientific title

Modulation of gut function using gut specific nutrients in the critically ill: a double blind, placebo controlled, randomised clinical trial

Acronym

GSN study

Study hypothesis

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

Scarborough Hospital Local Research Ethics Committee approved on the 1st March 2004 (ref: LREC/04/378)

Study design

Double-blind placebo-controlled randomised clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Glutamine, multivitamins and antioxidants [Forceval], probiotics [Trevis], oligofructose

Primary outcome measures

Time to the return of normal gut function, measured hourly from recruitment to return of gut function.

Secondary outcome measures

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

Overall trial start date

01/03/2004

Overall trial end date

30/07/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Critically ill patients (aged greater than or equal to 18 years, either sex) with inadequate gut function

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/03/2004

Recruitment end date

30/07/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of General Surgery
Scarborough
YO12 6QL
United Kingdom

Sponsor information

Organisation

Scarborough and North East Yorkshire Healthcare NHS Trust (UK)

Sponsor details

Scarborough General Hospital
Woodlands Drive
Scarborough
YO12 6QL
United Kingdom

Sponsor type

Government

Website

http://www.scarborough.nhs.uk/

Funders

Funder type

Government

Funder name

Scarborough and North East Yorkshire Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Combined Gastroenterology Research Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20629109

Publication citations

  1. Results

    Gatt M, MacFie J, Randomized clinical trial of gut-specific nutrients in critically ill surgical patients., Br J Surg, 2010, 97, 11, 1629-1636, doi: 10.1002/bjs.7155.

Additional files

Editorial Notes