Dietary Exposure
Conditions
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 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.
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 single arm, prospective, multi-centre study to evaluate the gastrointestinal tolerance and compliance over a fourteen-day period. Data will be collected using patient diaries to asses changes in GI tolerance and tube feed intake.
Interventions
DIETARY_SUPPLEMENTPeptamen 1.3 PHGG
The amount of tube feed will be assess by the health Care Professional.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess tolerance via patient diaries | 14 days | Daily assessment of diarrhoea, constipation, reflux, vomiting, wind, bloating |
| Daily formula intake | 14 days | mL |
Countries
United Kingdom
Outcome results
None listed