STEPP: Safety and tolerance of a peptide tube feed in ICU patients
Research type
Research Study
Full title
Safety and gastrointestinal Tolerance after administration of an Energy and Protein enriched Peptide formula in ICU patients as compared to an isocaloric standard tube feed
IRAS ID
205929
Contact name
G. Hofman
Contact email
Sponsor organisation
Nutricia Research
Duration of Study in the UK
1 years, 1 months, days
Research summary
Title: Safety and gastrointestinal Tolerance after administration of an Energy and Protein enriched Peptide formula in ICU patients as compared to an isocaloric standard tube feed
Tube-feeding is indicated for people with insufficient oral nutrient intake and a functional gastrointestinal (GI) tract. In ICU patients, GI intolerance is associated with a lower intake of the tube feed and worse clinical outcome. GI tolerance may be improved with a peptide feed (small protein particles). Nutricia Research developed a new peptide feed aiming to achieve a higher energy and protein intake in patients in need of tube feeding suffering from GI intolerance. This new peptide feed is suitable for patients in need of tube-feeding with low fluid requirements or high energy and/or protein requirements, especially those patients with or at risk of GI tolerance issues.
In this randomised controlled study, GI tolerance and safety of the new peptide feed will be compared with a commercially available tube feed with the same energy and protein amount (complete proteins) in 30 intensive care patients. ICU patients in need of tube feed and expected to receive tube feeding for a minimum period of 5 days will be included in the study. Patients will receive the new peptide feed or the commercially available tube feed during a period of maximal two weeks. The duration of the study for each subject will be up to 30 days including a follow-up phase. The study will be performed at the intensive care units of two hospitals in London area.
REC name
London - Bromley Research Ethics Committee
REC reference
16/LO/1139
Date of REC Opinion
21 Jun 2016
REC opinion
Unfavourable Opinion