Elemental 028 Extra case studies
Research type
Research Study
Full title
Evaluating the tolerance, compliance and acceptability of a nutritionally complete amino acid-based nutritional supplement for the dietary management of conditions with a severe impairment of the gastrointestinal tract in children and adults: a case study series
IRAS ID
329442
Contact name
Gary Hubbard
Contact email
Sponsor organisation
Nutricia
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
Elemental feeds, also referred to as amino acid-based, fully hydrolysed or pre-digested feeds, contain single amino acids as a source of protein and have a broad clinical application amongst patients with conditions where there is a severe impairment of the gastrointestinal tract, possibly due to maldigestion and/or malabsorption including inflammation, reduced concentration of digestive enzymes and/or reduced surface area for nutrient absorption associated with some diseases and treatments. Such conditions include gastrointestinal diseases or disorders, neurodisabilities and neuro-degenerative diseases, gynaecological cancers, and gastrointestinal impairment secondary to clinical treatment. Allergic diseases can also be managed with elemental feeds.
Elemental 028 Extra Elemental 028 Extra is a multi-nutrient, amino acid-based feed, MCT containing, nutritionally complete feed for patients who may require an elemental diet, available in both powder and liquid forms, in different flavours. Elemental 028 Extra provides healthcare professionals with a means to provide medical nutrition for those patients who may need a sole or supplementary source of nutrition in the format of an amino acid-based or elemental formula. An upgraded formulation of Elemental 028 Extra with an increased energy and protein content and an updated micronutrient profile has been developed to better meet the nutritional requirements of patients.
This series of case-studies aims to evaluate the acceptability, compliance, and gastrointestinal tolerance of the upgraded formulation of Elemental 028 Extra, in 30 adult and paediatric patients (15 powder and 15 liquid), with conditions where there is a severe impairment of the gastrointestinal tract, such as inflammatory bowel disease, short bowel syndrome, intractable malabsorption, allergic disease, and neurodegenerative diseases, and an elemental feed is required. The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
24/WM/0001
Date of REC Opinion
2 Feb 2024
REC opinion
Further Information Favourable Opinion