Status:

NOT_YET_RECRUITING

Elemental 028 Extra Case Studies

Lead Sponsor:

Nutricia UK Ltd

Conditions:

Gastrointestinal Disease

Inflammatory Bowel Disease (IBD)

Eligibility:

All Genders

3+ years

Phase:

NA

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...

Detailed Description

Medical nutrition feeds for the dietary management of gastrointestinal impairment and/or allergic diseases can be broadly classified into three categories according to the size of the protein source i...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06877923

Start Date

April 1 2025

End Date

February 1 2026

Last Update

April 18 2025

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