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Elemental 028 Extra Case Studies

RecruitingNAAges 3 Years - anyAllNutricia UK Ltd
NCT06877923 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 malab

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📋 Eligibility rules (as published)
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
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What it tests

  • Elemental 028 Extra
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Where

1 site
Nutricia UK
Trowbridge, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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