Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT05474105
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 and \<80
* Acute ischaemic stroke (within 24 h of onset), including the following subtypes according to the Trial of Org 10172 in Acute Stroke Treatment (TOAST) classification: large-artery atherosclerosis, cardio-embolism, small-vessel occlusion, stroke of undetermined aetiology OR Acute ischaemic stroke (within 24 h of onset) caused by arterial dissection.
* Pre-morbid (modified Rankin Scale) mRS of ≤2
* National Institutes of Health Stroke Scale (NIHSS) score \>4
* CT ASPECT score of ≥6 on presentation CT
* Expected ability to provide consent
* Ability to drink the ONS product within 7 days of incident stroke
Exclusion Criteria:
* Allergies to fish oil/milk/soya
* Known history of galactosaemia
* Patients that develop malignant middle cerebral artery (MCA) syndrome
* Current or previous haemorrhagic stroke including sub-arachnoid haemorrhage
* Patient with nasogastric (NG) tube
* Patients with dysphagia (routinely tested) who cannot drink the medical food
* Known malignancy
* Known pre-existing neurological disease including multiple sclerosis, Alzheimer's disease, Parkinson's disease, previous strokes
* Pregnant or breastfeeding
* Inability to complete the follow-up and/or Investigators uncertainty about the ability to complete the follow-up
* Chronic renal disease Stage 3b and above (I.e. Glomerular filtration rate (GFR) \< 44ml/min)
* Ischaemic stroke of other determined aetiology as classified by the TOAST classification (not including stroke caused by arterial dissection).
* Unable to receive enteral nutrition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05474105
Study Brief:
Protocol Section:
NCT05474105