Elemental 028 Extra Case Studies

Launched by NUTRICIA UK LTD · Mar 10, 2025

Keywords

ClinConnect Summary

The Elemental 028 Extra Case Studies are looking into a new type of nutritional feed designed for people with serious gastrointestinal conditions, like inflammatory bowel disease and short bowel syndrome. This upgraded formula provides all the essential nutrients, including proteins and vitamins, that patients need when their digestive system isn't working properly. The study will involve 30 patients, both adults and children, who will try this new feed for 28 days to see how well they tolerate it and if they find it acceptable.

To be eligible for this study, participants need to be over three years old and require this special feed to meet at least 30% of their daily energy needs. Those who are pregnant, breastfeeding, or have certain health issues will not be able to participate. During the study, patients will first have a one-day assessment before starting the new feed. This trial will take place across several centers in the UK, and the findings will help improve nutritional support for those with significant digestive challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female
• • Over 3 years of age
• • Requiring an elemental feed (at least 30% of total energy requirements)
• • Written or electronic informed consent from patient, and/or from parent/caregiver if applicable
• Exclusion Criteria:
• • Pregnant or lactating
• • Requiring parenteral nutrition
• • Major hepatic or renal dysfunction
• • Participation in other studies within 1 month prior to entry of this study
• • Investigator concern around willingness/ability of patient or parent/caregiver to comply with protocol requirements