Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03140371 |
| Other study ID # |
HEHP16 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 14, 2017 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
November 2023 |
| Source |
Nutricia UK Ltd |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Oral nutritional supplements and enteral tube feeds are commonly used to meet the nutritional
requirements of patients with disease-related malnutrition, or who require medical nutrition
support for other reasons. Some patients may not tolerate standard formulations containing
whole proteins (typically due to maldigestion/malabsorption) leading to gastrointestinal
symptoms (i.e. vomiting and diarrhoea). Without appropriate management, this may lead to
reduced nutritional intake, increased nutritional losses and risk of malnutrition in patients
who may already have elevated nutritional requirements due to their clinical conditions.
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.
Description:
Malnutrition or "undernutrition" in adults (≥18 years of age) is the deficiency of nutrients
(energy, protein and micronutrients) which causes adverse effects on bodily composition,
clinical and functional outcomes. Malnutrition can occur as a result of a number of factors
including inadequate calorie intake, impaired nutrient absorption
(malabsorption/maldigestion) or increased energy requirements usually associated with
disease/illness e.g. cancer, inflammatory bowel disease and pancreatitis, and its management,
e.g. chemotherapy and surgery. Patients who have or are at risk of malnutrition can be
managed with a range of nutrition support strategies, including the use of oral nutritional
supplements and enteral feeds (administered by feeding tubes such as nasogastric tubes,
gastrostomies or jejunostomies). These feeds may provide either a sole source of nutrition or
in combination with the diet.
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.
