NCT06877923

Elemental 028 Extra Case Studies

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Nutricia UK Ltd · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to support patients with severe impairment of the gastrointestinal tract who may require an elemental diet. An upgraded formulation of Elemental 028 Extra with an increased energy, protein content 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.

Detailed description

Medical nutrition feeds for the dietary management of gastrointestinal impairment and/or allergic diseases can be broadly classified into three categories according to the size of the protein source in the feed: polymeric, extensively or partially hydrolysed, and elemental feeds. Polymeric feeds contain whole protein sources, typically from milk, soy, or pea protein. Extensively or partially hydrolysed feeds, also referred to as oligopeptide or semi-elemental feeds, contain peptides which are on average 4-5 amino acids in length, and are typically hypoallergenic as the peptides are too short for antigen recognition or presentation. Elemental feeds, also referred to as amino acid-based, hydrolysed or pre-digested, 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, neuro-disabilities 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 is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to support patients with severe impairment of the gastrointestinal tract who may require an elemental diet. An upgraded formulation of Elemental 028 Extra with an increased energy, protein content and 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.

Conditions

• Gastrointestinal Disease
• Inflammatory Bowel Disease (IBD)
• Short Bowel
• Malabsorption
• Allergies
• Neurodegenerative Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Elemental 028 Extra	Elemental 028 Extra formulations. Both powder and liquid versions will be used

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-02-01
• Completion: 2027-02-01
• First posted: 2025-03-14
• Last updated: 2026-02-17

Locations

1 site across 1 country: United Kingdom