Acceptability and tolerance study of Peptamen HN PHGG
Research type
Research Study
Full title
To evaluate the acceptability (including gastrointestinal tolerance and compliance) of an adult peptide 1.3 kcal/ml tube-feed formula containing Partially Hydrolysed Guar Gum (PHGG) fibre.
IRAS ID
324753
Contact name
Stephanie Wakefield
Contact email
Sponsor organisation
Nestle Health Science
Duration of Study in the UK
0 years, 5 months, 27 days
Research summary
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance of an adult enteral peptide formula containing Partially Hydrolysed Guar Gum (PHGG) fibre ‘Peptamen® HN PHGG’ over a 14-day period.
‘Peptamen® HN PHGG’ is a food for special medical purpose used for the dietary management of short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, disease related malnutrition.
The study formula is a whey peptide enteral nutrition product containing 1.3 kcal/ml and 6g/L of PHGG fibre.
Each participant will receive the formula for up to 14 days and must complete a minimum of 7 days to be included in the final analysis.
The supervising dietitian will determine the target volume and rate of delivery on an individual basis, and the enteral formula will be administered via an enteral feeding tube.
The intended population for Peptamen HN PHGG is adults with high protein requirements who are at risk from intolerance to enteral feeding, maldigestion or malabsorption, in the acute or home care setting.
The study is of relevance to patients and healthcare professionals as it will provide data to be submitted from a minimum of 15 participants to apply to the Advisory Committee on Borderline Substances (ACBS) in the UK. For the ACBS we need data for 7 days, but we have extended the study to 14 days as in dietetic practice for some patients a switch to new tube feed formula may happen over 1-3 days
The Patients must be well established and stable on a standard enteral tube feed. Baseline questionnaire will be completed by a healthcare professional to capture current trends in gastrointestinal symptoms and medical history. 15 participants replace their usual feed with Peptamen® HN PHGG. They or their parent/caregiver complete a daily gastrointestinal tolerance diary for 14 days and formula intake for 14 days on usage, tolerance, acceptability, and compliance. A brief questionnaire will be completed at the end of the study on Day 14 by the healthcare professional to assess any changes to tolerance, compliance, and patient satisfaction. Once participants have completed the 14-day study product supply will stop and participants will return to their existing feeding regimen.REC name
North of Scotland Research Ethics Committee 2
REC reference
23/NS/0037
Date of REC Opinion
24 Apr 2023
REC opinion
Further Information Favourable Opinion