Acceptability and Tolerance Study of Peptide Feed with Fibre (NCT06102135) | Clinical Trial Compass
CompletedNot Applicable
Acceptability and Tolerance Study of Peptide Feed with Fibre
United Kingdom15 participantsStarted 2023-09-05
Plain-language summary
Enterally fed adults with documented evidence of gastrointestinal intolerance will be recruited. Participants will be deemed by the investigator as having a clinical indication for enteral feeding with a fibre containing peptide formula. Data from 15 participants are required in order to submit an application to the Advisory Committee on Borderline Substances (ACBS) for product registration.
Who can participate
Age range18 Years
SexALL
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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.