Clinical trial NCT05269992: Childrens Real Food Tolerance Study
Official title: Tolerance, Compliance and Acceptability to a New Nutritional Feed Comprising Real Food Ingredients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition, Child
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A prospective, longitudinal, 28-day intervention study evaluating the tolerance, compliance, acceptability and safety to two new enteral tube feed and one new oral nutritional supplement based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement).

Detailed description: Nutritional feeds in the form of either enteral tube feeds or oral nutritional supplements are commonly used to meet the entire or partial nutritional requirements of children who demonstrate faltering growth or other medical conditions where they cannot meet their nutritional requirements sufficiently either orally or with food alone. Prescribable commercially available enteral tube feeds and oral nutritional supplements are recommended for all patient groups by the National Institute for Clinical Excellence (NICE) and other professional bodies and are based on food ingredients such as milk powder, vegetable oils and vitamin/mineral mixes however, they are processed to some degree to ensure stability, sterility and standardised nutritional content.

In recent years some patient groups have begun to administer homemade blended foods via their feeding tubes, instead of using prescribable commercially available feeds, which is especially prevalent among paediatric patients. Although recognition of this practice from professional bodies is low, anecdotal evidence does show some benefits. Nonetheless, there are concerns with this practice including compromised nutritional consistency, microbiological safety and enteral pump and tube integrity. This presents a problem for some parents who wish to provide their child with a source of nutritional support based on real food without posing any additional risks. Nutricia has recognised the changing needs of these paediatric patients and has therefore extended its existing range of paediatric feeds to include new formulations which include real food ingredients whilst still maintaining sterility and a stabilised nutritional content. These new formulations are designed for children with faltering growth/disease related malnutrition from 1 year old, are suitable as a sole source of nutrition and provide a sterile, standardised consistency and nutritional content.

A clinical trial is therefore required to evaluate the tolerance, compliance, acceptability and safety of three new enteral tube feed and oral nutritional supplement formulations, based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement). Additional outcomes include nutritional intake, anthropometrics, and gastrointestinal health-related quality of life. This is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period. During the intervention period, patients will receive the intervention feed(s) as a sole source of nutrition or alongside any additional routine nutritional management as required.

Eligibility criteria: Inclusion Criteria:

* Children from 1 year to 16 years of age.
* Requiring oral or enteral nutritional support from a whole protein 1kcal/ml or a 1.5kcal/ml enteral tube feed (via an existing enteral feeding tube) or oral nutritional supplement for at least 28 days.
* Expected to receive a minimum of 300kcal/day from the study product(s).
* Informed consent obtained from the patient/carer.

Exclusion Criteria:

* Total parenteral nutrition (100% of requirements).
* Allergy to any of the study product ingredients.
* Severe galactose (galactosaemia) or lactose intolerance.
* Severe hepatic, metabolic or renal dysfunction.
* Requirement for a fibre free feed.
* Requirement for a hydrolysed, elemental or any other specialised feed.
* On high intensity chemotherapy or radiation therapy, pancreatitis, chylothorax, or Inflammatory Bowel Disease.

Primary outcomes:
measure: Gastrointestinal tolerance assessing abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence
timeFrame: 29 days
Secondary outcomes:
measure: Compliance
timeFrame: 29 days
measure: Functionality, perception and satisfaction with the study product
timeFrame: 29 days
measure: Energy and protein intake
timeFrame: 29 days
measure: Gastrointestinal health-related quality of life
timeFrame: 29 days
measure: Height
timeFrame: 29 days
measure: Weight
timeFrame: 29 days
measure: Dietetic Goal
timeFrame: 29 days
measure: Adverse events
timeFrame: 29 days
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
Study officials:
References: