Status:
COMPLETED
Acceptability and Tolerance Study of Peptide Feed with Fibre
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Dietary Exposure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wit...
Detailed Description
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult enteral peptide formula containing Partially Hydrolysed Guar Gum (PHGG) fibre in 15 patients. This is a ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06102135
Start Date
September 5 2023
End Date
September 3 2024
Last Update
September 23 2024
Active Locations (2)
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1
Nutrition and Dietetics
Liverpool, United Kingdom
2
Nutrition and Dietetics
Newcastle, United Kingdom