The FOOD Trial       

                    (Feed Or Ordinary Diet)                                       

                                                  Protocol Summary

                                                                                            Italian Protocol Summary

A Multicentre Trial to Evaluate Various Feeding Policies in Patients Admitted to Hospital with a Recent Stroke.

Clinicians vary in their feeding policies and more specifically, the timing and method of feeding patients after stroke. This variation results from a lack of reliable evidence concerning the optimal strategy. The aim of this 'family' of three trials is to identify the optimum feeding regimes for patients who have recently suffered a stroke.

Questions

The trials are addressing three main questions:

• In patients with recent stroke, who are unable to take an adequate fluids orally, does early initiation of tube feeding (NG or PEG) increase the proportion of patients with stroke surviving without severe disability?
• In patients with recent stroke who need tube feeding, is a PEG tube, instead of the traditional NG tube, associated with better outcomes?
• In patients with a recent stroke, who can take adequate fluids orally, does oral nutritional supplementation increase the proportion of patients surviving without disability?

Most patients are eligible for randomisation.

Any patient is eligible if admitted to hospital within seven days of stroke onset ( excluding those with subarachnoid haemorrhage) in whom the responsible clinician is substantially uncertain about the best feeding policy for that patient. Patients can be randomised any time within the first month of hospital admission. 

A 'Family' of three trials

The three trials use the same:

• randomisation form
• randomisation service
• data collection forms
• follow-up system

This makes it easier to take part in FOOD. Patients can be randomised in one,two or even all three trials, depending on their progress and how uncertain the responsible clinician is about the best way to feed the patient.

A Simple Randomisation Procedure

The randomising clinician fills in a one page form and then telephones our central randomisation service. The clinicians' answers to four simple questions ensures that the patient enters the most appropriate trial or trials (see randomisation algorithm). The form is then simply faxed to us and the allocated treatment started.

Follow-up

At hospital discharge, or earlier death, the responsible clinician completes one short form which records what feeding the patient was actually given and any complications which occurred. Six months after the first randomisation the national Coordinating Centre will follow the patient up using a postal or telephone questionnaire to confirm the patient's survival, functional status and quality of life.

Analyses

All analyses will be based on intention to treat. The primary outcome measures are based on the Modified Rankin Scale. At least 9000 patients will be randomised.

For further details please contact:

Prof. Martin Dennis (Clinical Co-ordinator) or Gina Cranswick (Trial Co-ordinator) by email at food@skull.dcn.ed.ac.uk or at the address below.

The FOOD Trial Co-ordinating Centre                                                                        
Neurosciences Trials Unit                                                                                                            
Western General Hospital               
Edinburgh EH4 2XU
Scotland
Tel: +44 (0) 131 537 3126                                                                                                                                 
Fax: +44 (0) 131 332 5150