Elemental 028 Extra Case Studies
Not applicable · Testing Elemental 028 Extra · 1 site · Nutricia UK Ltd
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Elemental 028 Extra (a dietary supplement) as a possible treatment. Condition(s) listed: Gastrointestinal Disease, Inflammatory Bowel Disease (IBD) and Short Bowel.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 3 and older
- Any sex
Some of the main requirements, copied from the record:
- Male or female
- Over 3 years of age
- Requiring an elemental feed (at least 30% of total energy requirements)
Plus 1 more requirement(s). There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2025-05-01.
- Main results expected around 2027-02 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United Kingdom.
Main thing being measured
- Gastro-intestinal tolerance (Will be recorded at baseline (day 1) and end of intervention (day 29))
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Gastrointestinal Disease; Inflammatory Bowel Disease (IBD); Short Bowel; Malabsorption; Allergies; Neurodegenerative Disorders |
| Lead sponsor | Nutricia UK Ltd |
| Enrollment | 30 (estimated) |
| Start date | 2025-05-01 |
| Primary completion (est.) | 2027-02 |
| First posted | 2025-03-14 |
| Last updated | 2026-02-17 |
| 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 |
| ClinicalTrials.gov ID | NCT06877923 |
Interventions
- Elemental 028 Extra (Dietary Supplement)
Elemental 028 Extra formulations. Both powder and liquid versions will be used
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Nutricia UK | Trowbridge | United Kingdom | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.