Elemental 028 Extra Case Studies

NCT06877923 | Recruiting

• 2 other identifiers: E028E329442
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Disease; Inflammatory Bowel Disease (IBD); Short Bowel; Malabsorption; Allergies; Neurodegenerative Disorders

Outcome Measures

Primary Outcomes (1)

• Gastro-intestinal tolerance

  Gastro-intestinal (GI) tolerance will be recorded by the Dietitian at baseline on Day 1 and at the end of the case study period. GI tolerance will be recorded using a standardised questionnaire (rating their symptoms from None, Mild, Moderate to Severe), to be completed by the patient or caregiver, as appropriate. Patients and/or parents/caregivers will be asked to record their symptoms in the past 24 hours and as an average over the case study period.

  Will be recorded at baseline (day 1) and end of intervention (day 29)

Secondary Outcomes (3)

• Acceptability

  Measured at baseline (day 1) and end of intervention period (day 29).

• Compliance

  Measured at baseline (day 1) and end of intervention period (day 29).

• Anthropometry

  Measured at baseline (day 1) and end of intervention period (day 29).

Other Outcomes (2)

• Patient history

  Measured at baseline only.

• Safety

  Measured throughout the full study period. From day 1 through to day 29.

Study Arms (1)

Elemental 028 Extra New Formulation

EXPERIMENTAL

Dietary Supplement: Elemental 028 Extra

Interventions

Elemental 028 Extra DIETARY_SUPPLEMENT

Elemental 028 Extra formulations. Both powder and liquid versions will be used

Elemental 028 Extra New Formulation

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nutricia UK Ltd: lead

Study Sites (1)

Nutricia UK

Trowbridge, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Diseases; Inflammatory Bowel Diseases; Malabsorption Syndromes; Hypersensitivity; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Gastroenteritis; Intestinal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Immune System Diseases; Nervous System Diseases

Study Officials

• Gary Hubbard

  Nutricia UK

  STUDY DIRECTOR

Central Study Contacts

Isabel Evans

CONTACT

+44 7385 000738; isabel.evans@nutricia.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 14, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

GB (1)