| NCT ID | NCT06877923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nutricia UK Ltd |
| Condition | Gastrointestinal Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-05-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 content micronutrient profile has been developed to better meet the nutritional requirements of patients. This series of case-studies aims to evaluate the acceptability, compliance, and gastrointestinal tolerance of the upgraded formulation of Elemental 028 Extra, in 30 adult and paediatric patients (15 powder and 15 liquid), with conditions where there is a severe impairment of the gastrointestinal tract, such as inflammatory bowel disease, short bowel syndrome, intractable malabsorption, allergic disease, and neurodegenerative diseases, and an elemental feed is required. The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies.
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
Contact & Investigator
Gary Hubbard
STUDY DIRECTOR
Nutricia UK
Frequently Asked Questions
Who can join the NCT06877923 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, studying Gastrointestinal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06877923 currently recruiting?
Yes, NCT06877923 is actively recruiting participants. Contact the research team at isabel.evans@nutricia.com for enrollment information.
Where is the NCT06877923 trial being conducted?
This trial is being conducted at Trowbridge, United Kingdom.
Who is sponsoring the NCT06877923 clinical trial?
NCT06877923 is sponsored by Nutricia UK Ltd. The principal investigator is Gary Hubbard at Nutricia UK. The trial plans to enroll 30 participants.