Status:
RECRUITING
Childrens Real Food Tolerance Study
Lead Sponsor:
Nutricia UK Ltd
Conditions:
Malnutrition, Child
Eligibility:
All Genders
1-16 years
Phase:
NA
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...
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 falterin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05269992
Start Date
May 1 2022
End Date
December 31 2025
Last Update
February 26 2025
Active Locations (1)
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1
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ