Elemental 028 Extra case series
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
NA · Nutricia UK Ltd · NCT06877923
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 3 Years and up |
| Sex | All |
| Sponsor | Nutricia UK Ltd (industry) |
| Locations | 1 site (Trowbridge) |
| Trial ID | NCT06877923 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Trowbridge
- Nutricia UK — Trowbridge, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Isabel Evans
- Email: isabel.evans@nutricia.com
- Phone: +44 7385 000738
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gastrointestinal Disease, Inflammatory Bowel Disease, Short Bowel, Malabsorption, Allergies, Neurodegenerative Disorders