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 @ 11:41 PM
Ignite Modification Date:
2025-12-24 @ 11:41 PM
NCT ID:
NCT06034951
Eligibility Criteria:
Inclusion Criteria:
* Patients requiring an enteral tube feed (taking \> 60% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
* Children 15 years and over
* Adults and children requiring an adult high-energy and fibre-containing formula, as assessed by the dietitian.
* Patients well-established and stable on enteral feeding.
* Willingly given, written, informed consent from patient or consultee
* Willingly given, written assent (if appropriate).
Exclusion Criteria:
* Inability to comply with the study protocol, in the opinion of the investigator
* Children under 15 years of age
* Patients receiving mechanical ventilation, sedation or inotropic support
* Patients on total parenteral nutrition
* Known food allergies to any ingredients (see ingredients list) or galactosaemia
* Patients with significant renal or hepatic impairment
* Patients with planned changes to medication or treatments during the study period which may alter gastrointestinal function (e.g. chemotherapy). Changes in medications or nutritional products during the study intervention must be documented.
* Participation in another interventional study within 2 weeks of this study.
* Patients with a clinical indication for a low fibre or fibre free diet as advised by the healthcare team.
* Patients with known or suspected ileus or mechanical bowel obstruction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT06034951
Study Brief:
Protocol Section:
NCT06034951