Childrens Real Food Tolerance Study

Launched by NUTRICIA UK LTD · Feb 25, 2022

Keywords

ClinConnect Summary

The Children's Real Food Tolerance Study is a research trial designed to understand how well children can tolerate and accept new types of nutritional support made from real food ingredients. This study lasts for 28 days and focuses on children aged 1 to 16 who need help with their nutrition, either through a feeding tube or by taking a nutritional drink. Eligible children should be expected to receive at least 300 calories a day from the study products, which come in two forms: a tube feed and an oral supplement.

If your child is eligible and decides to participate, they will be monitored throughout the study to ensure their safety and to see how well they handle the new feeding options. It's important to note that children with certain medical conditions, such as severe allergies, specific metabolic disorders, or those on certain treatments, may not be able to join the trial. Overall, this study aims to improve nutritional support options for children who need it, using products that are based on real food to help them thrive.

Gender

ALL

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.