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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT06102135
Eligibility Criteria:
Inclusion Criteria:
* Enterally fed adults feeding taking ≥60% of nutritional requirements from enteral nutrition
* Patients with documented evidence of feeding intolerance or GI symptoms during enteral feeding, and who in the clinical judgement of the supervising dietitian may benefit from a peptide formula with fibre.
* Aged 18 years and above.
* Willingly given, written, informed consent from patient
Exclusion Criteria:
* Inability to comply with the study protocol, in the opinion of the investigator
* 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:
18 Years
Study:
NCT06102135
Study Brief:
Protocol Section:
NCT06102135