Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2017-07-14
2022-12-31
Brief Summary
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Poor tolerance to standard feed formulations can be managed with extensively hydrolysed (peptide-based) enteral feeds, where the protein source is provided in smaller proteins. Patients with elevated nutritional requirements, poor tolerance, maldigestion and/or malabsorption often require a higher energy, higher protein feed to meet their nutritional requirements in a smaller volume of feed.
The study feed is a high energy (1.5kcal/ml), high protein (7.5g protein/100ml) peptide-based feed, available as a 500ml enteral tube feed, and a 200ml Vanilla-flavour oral nutritional supplement. The study will investigate the gastrointestinal tolerance, compliance and acceptability of the high energy, high protein peptide-based feed in 60 adult patients requiring a peptide-based feed, in several NHS sites across England. Patients will be asked to take the study feed for 28 days. Data will be recorded using questionnaires with no invasive measures.
The primary outcome is gastrointestinal tolerance with secondary outcomes of compliance, acceptability, nutrient intake and anthropometry.
Detailed Description
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A small group of patients requiring nutritional support experience severe malabsorption and maldigestion of nutrients (particularly protein and fat), resulting in them having an inadequate energy and nutrient supply. This may be due to inadequate functioning of the gastro-intestinal tract due to inflammation, reduced concentration of digestive enzymes and/or reduced surface area for nutrient absorption associated with some diseases and treatments. These may include patients with pancreatic enzyme deficiency (pancreatitis, pancreatic cancer, cystic fibrosis), inflammatory bowel disease, radiation enteritis and chemotherapy, short bowel syndrome, HIV-related gastrointestinal disorders, enteric fistulae or intolerance/allergy of unknown cause. Some of these patients will not be able to tolerate a standard feed containing whole protein and fat. In these cases oral nutritional supplements and enteral tube feeds known as 'extensively hydrolysed', 'semi-elemental' or 'peptide-based' with extensively digested protein (containing peptides and small proteins) and containing more easily absorbed types of fat (medium chain triglycerides (MCTs)), can help improve digestion and absorption.
Peptide-based feeds have been used effectively in the dietary management of patients with Crohn's disease, pancreatitis, pancreatectomy, radiation enteritis and chemotherapy, HIV-related GI disorders and short bowel syndrome. The use of MCTs in patients with fat (long chain triglyceride (LCT)) malabsorption has been shown to decrease steatorrhoea, decrease dyspepsia and improve nutritional status. Feed formulations with a mixture of MCTs and LCTs are also thought to provide beneficial effects.
Such specialised, ready to use feeds have been commonly used in clinical practice for many years. However, the energy density (1kcal/ml) and the protein content (4g/100ml) of some such feeds have meant that patients are often unable to tolerate the required volumes of feed either orally or via tube to meet their nutritional requirements, which are often elevated by their disease. Therefore, in order to meet the nutritional requirements of patients with poor feed tolerance, a more energy dense (1.5kcal/ml), higher protein (7.5g protein/100ml), nutritionally complete peptide-based feed for oral and tube feeding may be required.
The study feed is a high energy (1.5kcal/ml), high protein (7.5g protein/100ml) peptide-based feed, available as a 500ml enteral tube feed, and a 200ml Vanilla-flavour oral nutritional supplement. However, the tolerance, compliance and acceptability of this feed is unknown in this patient group who have complex clinical conditions. Therefore this study is required to assess gastrointestinal tolerance, compliance and acceptability of this high energy density (1.5kcal/ml), high protein (7.5g/100ml), peptide-based feed in community patients requiring nutrition support in clinical practice.
60 adult patients requiring a peptide-based feed will be recruited from several NHS sites across England. Patients will be asked to take the study feed for 4 weeks (28 days), in a quantity advised by their Dietitian. Data will be recorded at baseline, Week 4 and throughout the study using questionnaires with no invasive measures.
The primary outcome is gastrointestinal tolerance with secondary outcomes of compliance to prescribed study feed volumes, acceptability of the study feed, nutrient intake and anthropometry.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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High energy high protein peptide feed
This is a one-arm study. Each patient recruited onto the study will receive the high energy, high protein peptide-based feed for a period of up to 4 weeks (28 days). The feed will be available as an enteral tube feed in a 500ml bottle, and as a Vanilla flavoured oral nutritional supplement in a 200ml plastic bottle. The appropriate feed presentation (tube feed or oral nutritional supplement) and prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management, based on the patient's clinical requirement and preference, and the Dietitian's clinical judgement.
The study feed is classed as a 'Dietary Food for Special Medical Purposes' (EC Directive 1999/21/EC, 1999) .
High energy high protein peptide feed study
Each patient will receive the high energy, high protein peptide-based feed for a period of up to 4 weeks (28 days). The feed will be available as an enteral tube feed in a 500ml bottle, and as a Vanilla flavoured oral nutritional supplement in a 200ml plastic bottle. The appropriate feed presentation (tube feed or oral nutritional supplement) and prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management, based on the patient's clinical requirement and preference, and the Dietitian's clinical judgement.
The study feed is classed as a 'Dietary Food for Special Medical Purposes' (EC Directive 1999/21/EC, 1999) .
Interventions
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High energy high protein peptide feed study
Each patient will receive the high energy, high protein peptide-based feed for a period of up to 4 weeks (28 days). The feed will be available as an enteral tube feed in a 500ml bottle, and as a Vanilla flavoured oral nutritional supplement in a 200ml plastic bottle. The appropriate feed presentation (tube feed or oral nutritional supplement) and prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management, based on the patient's clinical requirement and preference, and the Dietitian's clinical judgement.
The study feed is classed as a 'Dietary Food for Special Medical Purposes' (EC Directive 1999/21/EC, 1999) .
Eligibility Criteria
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Inclusion Criteria
* Age 18 years and over
* Requiring a peptide-based feed to meet nutritional requirements
* Expected to receive at least 300kcal if taken orally or at least 500kcal if taken by tube
Exclusion Criteria
* Patients with major hepatic dysfunction (i.e. decompensated liver disease)
* Patients with major renal dysfunction (i.e. requiring filtration or Stage 4/5 chronic kidney disease (CKD))
* Patients in intensive care
* Patients with galactosaemia or severe lactose intolerance
* Participation in other clinical studies within 2 weeks prior to entry of this study
* Investigator concern around willingness/ability of patient to comply with protocol requirements
18 Years
ALL
No
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
Nutricia UK Ltd
INDUSTRY
Responsible Party
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Locations
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Cumbria Partnership NHS Foundation Trust
Whitehaven, Cumbria, United Kingdom
Derby Teaching Hospitals NHS Foundation Trust
Derby, Derbyshire, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, Gloucestershire, United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Guildford, Lonodn, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Frimley Health NHS Foundation Trust
Frimley, , United Kingdom
Guys and St Thomas NHS Foundation Trust
London, , United Kingdom
Lewisham and Greenwich NHS Foundation Trust
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, , United Kingdom
Great Western Hospitals NHS Foundation Trust
Swindon, , United Kingdom
Countries
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Other Identifiers
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HEHP16
Identifier Type: -
Identifier Source: org_study_id