Elemental 028 Extra case series
Official 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
Run by Nutricia UK Ltd · NCT06877923 · Data updated 2026-11-12
This project will try an upgraded Elemental 028 Extra amino-acid feed in adults and children with severe gut problems who need an elemental diet to see if they tolerate it and can stick with it.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Nutricia UK Ltd Industry-sponsored |
| Locations | 1 site (Trowbridge) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT06877923 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults and children aged over 3 years with severe gastrointestinal impairment (for example IBD, short bowel, malabsorption, or allergic disease) who require at least 30% of their daily energy from an elemental feed are the intended participants.
✕Probably not a fit
Patients who are pregnant or lactating, require parenteral nutrition, or have major liver or kidney dysfunction are excluded and unlikely to benefit from participation in this case series.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-arm case series will give an upgraded formulation of Elemental 028 Extra (higher energy, protein and micronutrient profile) to 30 patients with severe gastrointestinal impairment who require an elemental feed. Participants will include adults and children over age 3, with 15 receiving the powder form and 15 the liquid form, and the feed will provide at least 30% of total energy requirements. The study will record acceptability, compliance, and gastrointestinal tolerance over the treatment period and exclude those who are pregnant, lactating, on parenteral nutrition, or have major hepatic or renal dysfunction. The work is sponsored and run by Nutricia UK at a single site in Trowbridge, UK.
Why it matters
Potential benefit: If successful, the upgraded formulation could improve nutritional intake and gastrointestinal tolerance for patients who rely on elemental feeds.
How similar studies have gone: Amino-acid (elemental) feeds are an established option for severe GI impairment and allergic disease, but this specific upgraded higher-energy/higher-protein formulation has limited prior clinical testing.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Nutricia UK
Trowbridge, United Kingdom Recruiting
Study contacts
- Study coordinator: Isabel Evans
- Email: isabel.evans@nutricia.com
- Phone: +44 7385 000738
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.