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Clinical Trials in the UK / NCT05269992
Active, not recruiting Not applicable

Childrens Real Food Tolerance Study

NCT05269992 · tracked via the Priya Life Science UK tracker
Sponsor
Nutricia UK Ltd
Phase
Not applicable
Started
2022-05-01
Last updated
2026-04-14

Condition(s) studied

Malnutrition, Child

Investigational drug(s) / intervention(s)

Real food products

Real food products: As per arm/group descriptions.

Study 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

Sex
ALL
Min age
1 Year
Max age
16 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Gastrointestinal tolerance assessing abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence — 29 days
    Gastrointestinal tolerance will be assessed at baseline (day 1) in relation to patients' usual enteral tube feed, oral nutritional supplement or other nutritional regimen, and again at day 8, 15, 22 and 29 during the intervention using standardised questionnaires.Parents/carers will be asked to complete a gastrointestinal symptom score form on behalf of their child which will assess the incidence and severity of the following symptoms: abdominal discomfort, pain, nausea, reflux, regurgitation, gagging, retching, vomiting, constipation, diarrhoea, bloating and flatulence on a four-point scale (Absent, Mild, Moderate, Severe).

Trial sites (1)

FacilityCityRegionStatus
Bristol Royal Hospital for Children Bristol United Kingdom

More Nutricia UK Ltd trials in the UK

PKU Microtablets Case Studies Starting soon
Plant-Protein Dominant Tube Feed Study Recruiting
Elemental 028 Extra Case Studies Recruiting
Hydrolysed Rice Formula Study Recruiting
Evaluation of Four New Ready to Drink Oral Nutritional Supplements: Adult ONS Trial Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05269992 on ClinicalTrials.gov ↗ ← All trials in the UK