Evaluating Tolerance, Compliance, and Acceptability of an Upgraded Elemental Amino Acid-Based Nutritional Supplement for Severe Gastrointestinal Impairment in Children and Adults: A Case Study Series

What this Trial Is About

Researchers are evaluating an upgraded formulation of Elemental 028 Extra, a nutritionally complete amino acid-based feed designed for patients with severe gastrointestinal tract impairments. This case study series focuses on assessing the acceptability, compliance, and gastrointestinal tolerance of the new formulation in both adult and pediatric patients who need an elemental diet due to conditions such as inflammatory bowel disease, short bowel syndrome, malabsorption, allergic diseases, and neurodegenerative disorders. Participants will receive either the powder or liquid versions of the upgraded Elemental 028 Extra feed, which contains increased energy, protein content, and micronutrients to better meet patient needs. The study includes a 1-day baseline period followed by a 28-day intervention period during which the feed is used as a sole source of nutrition. This research is conducted across multiple centers in the UK to meet regulatory requirements for acceptability studies. During the 29-day study, participants will be monitored for gastrointestinal tolerance, acceptability, compliance, and anthropometric measurements at both the start and end of the intervention. Data collection includes assessments of these outcomes to understand how well patients tolerate and adhere to the upgraded feed. The study does not include blinding and follows a protocol designed to ensure patient safety and accurate data on the nutritional supplement's use.

Elemental 028 Extra Case Studies