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.
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
Pregnant or lactating
Requiring parenteral nutrition
Major hepatic or renal dysfunction
Participation in other studies within 1 month prior to entry of this study
Single group
Elemental 028 Extra
Dietary supplementElemental 028 Extra formulations. Both powder and liquid versions will be used
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.
Acceptability
Acceptability (ease of use and liking) of the patients' usual/current feed will be assessed by the Dietitian at baseline (Day 1) and of the study product at the end of the case study period by a series of questions posed to the patient and/or parent/caregiver. Acceptability questions will assess the patient's sensory experience, ease of use, tolerance, and overall self-rated acceptability on a 5-point Likert scale (rating from Great to Terrible).
Compliance
Compliance (volume and % of product consumed) with the prescribed intake of the patients' current feed(s) (before starting the intervention period) and with the study product (during the intervention period) will be assessed by the Dietitian at baseline (Day 1) and at the end of the case study period, respectively. Patients and/or parents/caregivers will be asked to recall the volume of feed consumed in the past 24 hours and on average. This will be compared to the amount recommended to consume by their Dietitian. The daily amount prescribed by the Dietitian managing the patient's care will be recorded at the start of the case study and any changes to this prescription during the case study will also be noted
Anthropometry
For safety purposes, at baseline (Day 1) and at the end of the case study, body weight (kg) will be measured where possible using standard methods, recorded to the nearest 0.1kg using a weighing scale without heavy clothing. Height will also be measured, using standard methods, recorded to the nearest 0.1cm (at baseline only) and used to calculate body mass index (BMI, kg/m2).
Patient history
A detailed patient history will be recorded at baseline to assess previously prescribed nutrition feeds, relevant medical and clinical issues, medication(s) prescribed, and any other relevant information related to the patient's condition or dietary management.
Safety
All adverse events will be recorded, throughout the case study.
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