RecruitingNot ApplicableNCT05269992

Childrens Real Food Tolerance Study

Tolerance, Compliance and Acceptability to a New Nutritional Feed Comprising Real Food Ingredients

Sponsor

Nutricia UK Ltd

Enrollment

60 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

Malnutrition, Child

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).

Eligibility

Min Age: 1 YearMax Age: 16 Years

Inclusion Criteria4

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 Criteria7

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.

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