Elemental 028 Extra Case Studies

NCT ID: NCT06877923

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-02-28

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.

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 in the feed: polymeric, extensively or partially hydrolysed, and elemental feeds. Polymeric feeds contain whole protein sources, typically from milk, soy, or pea protein. Extensively or partially hydrolysed feeds, also referred to as oligopeptide or semi-elemental feeds, contain peptides which are on average 4-5 amino acids in length, and are typically hypoallergenic as the peptides are too short for antigen recognition or presentation. Elemental feeds, also referred to as amino acid-based, hydrolysed or pre-digested, contain single amino acids as a source of protein and have a broad clinical application amongst patients with conditions where there is a severe impairment of the gastrointestinal tract possibly due to maldigestion and/or malabsorption including inflammation, reduced concentration of digestive enzymes and/or reduced surface area for nutrient absorption associated with some diseases and treatments. Such conditions include gastrointestinal diseases or disorders, neuro-disabilities and neuro-degenerative diseases, gynaecological cancers, and gastrointestinal impairment secondary to clinical treatment. Allergic diseases can also be managed with elemental feeds.

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 and 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Elemental 028 Extra New Formulation

Group Type: EXPERIMENTAL

Elemental 028 Extra

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Elemental 028 Extra

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia UK Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Hubbard

Role: STUDY_DIRECTOR

Nutricia UK

Central Contacts

Isabel Evans

Role: CONTACT

isabel.evans@nutricia.com

+44 7385 000738

Marta Delsoglio

Role: CONTACT

marta.delsoglio@nutricia.com

+44 7920 530707

Other Identifiers

329442

Identifier Type: OTHER

Identifier Source: secondary_id

E028E

Identifier Type: -

Identifier Source: org_study_id