Childrens Real Food Tolerance Study

NCT ID: NCT05269992

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2025-12-31

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.

Conditions

Malnutrition, Child

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Real food products

The study products are 1) a 1kcal/ml enteral tube feed provided as a 500ml ready to use enteral tube feed; 2) a 1.5kcal/ml enteral tube feed provided as a 500ml ready to use enteral tube feed, and 3) a 1.5kcal/ml oral nutritional supplement provided in a 200ml ready to drink format. This study is a prospective, longitudinal, 28-day intervention study with a 1-day baseline period aiming to recruit 60 in paediatric patients. During the intervention period, patients will receive one of the three study products (or more if deemed appropriate) for 28 days as a sole source of nutrition or alongside any additional routine nutritional management as required. As such, randomisation was not deemed suitable for this study. The appropriate study product and volume prescribed will be recommended by the investigating dietitian/nurse and agreed with the patient/parent/carer based on their clinical and nutritional requirements.

Group Type: EXPERIMENTAL

Real food products

Intervention Type: OTHER

As per arm/group descriptions.

Interventions

Real food products

As per arm/group descriptions.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia UK Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bristol Royal Hospital for Children

Bristol, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Benjamin Green, PhD

Role: CONTACT

ben.green@nutricia.com

07920587679

Facility Contacts

Lisa Cooke

Role: primary

Other Identifiers

NN001

Identifier Type: -

Identifier Source: org_study_id