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:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT03013803
Eligibility Criteria:
Inclusion criteria:
* Male and female participants ≥ 18 years of age
* Assessed to have malnutrition or be at risk of malnutrition by a Dietician within the investigator team. Assessment to include, but not limited to weight loss history, current BMI/MUST score, anamnesis, dietary intake history and predicted future oral intake.
* Anticipated period of nutritional support ≥ 12 days
* Patient has the capacity and is willing to provide informed consent.
Exclusion criteria:
* Participants with mental in capabilities who are unable to give informed consent
* Hypersensitivity to any of the active substances or excipients within the IP
* Severely impaired gastrointestinal function or complete failure
* More than 50% of nutrition from Parenteral Nutrition
* Simultaneous participation in another interventional study
* Participants who are unwilling or mentally and/or physically unable to adhere to study procedures
* Participants with dysphagia requiring thickened fluids
* Participants with significant renal impairment (CKD)
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03013803
Study Brief:
Protocol Section:
NCT03013803