A multicentre international randomised trial to evaluate percutaneous endoscopic gastrostomy (PEG) and nasogastric (NG) tube feeding in patients admitted to hospital with a recent stroke

ISRCTN	ISRCTN65375365
DOI	https://doi.org/10.1186/ISRCTN65375365
Secondary identifying numbers	HTA 96/29/01

Submission date: 20/03/2002
Registration date: 20/03/2002
Last edited: 09/07/2014

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr MS Dennis
Scientific

FOOD Trial Co-ordinating Centre
Neurosciences Trials Unit
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom

Phone	+44 (0)131 5372939
Email	MSD@skull.dcn.ed.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet
Scientific title
Study acronym	FOOD
Study objectives	FOOD is an international, randomised trial involving a total of at least 4,000 patients which aims to address the following issues: 1. In stroke patients who cannot swallow, does feeding via a Percutaneous Endoscopic Gastrostomy (PEG) tube improve survival free of severe disability compared with that via a nasal gastric (NG) tube? (500 patients in each arm) 2. In patients who cannot swallow within the first week of admission, is immediate initiation of feeding via either a PEG or NG tube (rather than simply hydrating the patient to see if dysphagia will rapidly resolve) associated with improved outcomes? (500 patients in each arm) We will assess the impact of particular feeding regimes on lower complication rates, mortality, improved quality of life amongst survivors and resource use. Using the same trial infrastructure we will also address a third related question: in patients who can swallow, does routine addition of oral nutritional supplements to the normal hospital diet improve patients' outcomes? (1000 patients in each arm). No additional resources are requested to address this third question. We believe that the inclusion of a trial addressing this last question will facilitate the more rapid completion of the tube feeding arms. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/962901 On 16/01/2008 the start and end date of this trial were changed from 1/11/1996 and 31/07/2003 to 01/02/1999 and 31/12/2004, respectively.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Stroke
Intervention	Interventions: Trial 1: Normal hospital diet versus normal hospital diet plus oral supplements (comprising 120 ml containing 1.5 kcal/ml three times a day) Trial 2: Immediate tube feeding (NG or PEG) versus delay tube feeding for at least a week and hydrate using parenteral fluids Trial 3: NG versus PEG
Intervention type	Other
Primary outcome measure	Survival without disability, mortality
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/02/1999
Completion date	31/12/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	4,023
Key inclusion criteria	Any patient admitted to hospital with a stroke (excluding those with subarachnoid haemorrhage) within a week of onset, in whom the randomising clinician is substantially uncertain about the best feeding policy
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/02/1999
Date of final enrolment	31/12/2004

Locations

Countries of recruitment

Argentina
Australia
Belgium
Brazil
Canada
Czech Republic
Denmark
Hong Kong
India
Ireland
Italy
New Zealand
Poland
Portugal
Scotland
Singapore
Türkiye
United Kingdom

Study participating centre

FOOD Trial Co-ordinating Centre

Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

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	Peer reviewed?	Patient-facing?
Results article	results	01/02/2005	Yes	No
Results article	results	01/02/2005	Yes	No
Results article	results	01/01/2006	Yes	No