An interventional study of Elemental 028 Extra in Gastrointestinal Disease, Inflammatory Bowel Disease (IBD) and Short Bowel, sponsored by Nutricia UK Ltd. Recruiting at 1 site in United Kingdom. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Nutricia UK Ltd (part of Danone) · Not applicable, Interventional, and Treatment
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.
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.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's planned enrollment of 30 is below the median of 68 across 870 interventional studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Nutricia UK Ltd is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Compared within Inflammatory Bowel Diseases, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gastrointestinal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Elemental 028 Extra
Elemental 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.
Time frame: Will be recorded at baseline (day 1) and end of intervention (day 29)
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).
Time frame: Measured at baseline (day 1) and end of intervention period (day 29).
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
Time frame: Measured at baseline (day 1) and end of intervention period (day 29).
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).
Time frame: Measured at baseline (day 1) and end of intervention period (day 29).
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.
Time frame: Measured at baseline only.
Safety
All adverse events will be recorded, throughout the case study.
Time frame: Measured throughout the full study period. From day 1 through to day 29.
Started May 2025 (actual). Primary completion is estimated for Feb 2027, 21 months after the start.
Of 296 interventional studies with no phase under Inflammatory Bowel Diseases, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 21 months is below that.
How these figures are worked out, and which studies are left out of them.
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