Evaluating real food nutritional support for children
Tolerance, Compliance and Acceptability to a New Nutritional Feed Comprising Real Food Ingredients
This study is testing new nutritional products made from real food to see if they are safe and effective for children aged 1 to 16 who need extra feeding support due to health issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 1 Year to 16 Years |
| Sex | All |
| Sponsor | Nutricia UK Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bristol) |
| Trial ID | NCT05269992 on ClinicalTrials.gov |
What this trial studies
This study is a 28-day intervention that assesses the tolerance, compliance, acceptability, and safety of two new enteral tube feeds and one oral nutritional supplement made from real food ingredients. It aims to provide nutritional support for children aged 1 to 16 who require oral or enteral feeding due to malnutrition or other medical conditions. The study will compare these new products against traditional commercially available feeds, focusing on their effectiveness and safety in meeting children's nutritional needs. Participants will receive a minimum of 300kcal/day from the study products.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 16 years who need oral or enteral nutritional support for at least 28 days.
Not a fit: Patients who are on total parenteral nutrition or have severe allergies to the study product ingredients will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more acceptable nutritional option for children who require enteral feeding.
How similar studies have performed: While there is anecdotal evidence supporting the use of homemade blended foods, this approach is relatively novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bristol
- Bristol Royal Hospital for Children — Bristol, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Benjamin Green, PhD
- Email: ben.green@nutricia.com
- Phone: 07920587679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.