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Recruiting Not applicable

Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.

NCT07210658 · tracked via the Priya Life Science UK tracker
Phase
Not applicable
Started
2025-04-14
Last updated
2026-01-09

Condition(s) studied

Paediatrics

Investigational drug(s) / intervention(s)

Oral nutritional supplementation

Oral nutritional supplementation: As directed by the HCP

Study summary

Acceptability, compliance and palatability study.

Eligibility

Sex
ALL
Min age
1 Year
Max age
16 Years
Healthy volunteers
No
Inclusion Criteria: * Patients from 1-15 years requiring 1 or more oral nutritional supplement to replace current oral nutritional supplement as part of their dietary management for disease related malnutrition. * Patients well-established and stable on current nutritional support regimen. * Willingly given, written, informed consent from patient/caregiver. Exclusion Criteria: * Unsafe swallow * Inability to comply with the study protocol, in the opinion of the investigator. * Under 1 years of age * Patients on total parenteral nutrition * Known food allergies, including any allergies to the ingredients * Patients with Chronic Kidney Disease (CKD) stage 3b (G3b), stage 4 (G4), stage 5 (G5) or hepatic impairment. * Participation in another interventional study within 2 weeks of this study. * Patients with known or suspected ileus or mechanical bowel obstruction

Primary outcome measure(s)

  • Gastrointestinal tolerance — Days 1-7, and at day 14, 21 and 28
    Number of children who experienced gastrointestinal symptoms such as reflux, vomiting, nausea, constipation, diarrhoea recorded as a 4 point Likert scale as none, mild, moderate, severe symptoms at baseline and at post switch.

Trial sites (1)

FacilityCityRegionStatus
Dietetics Nottingham United Kingdom 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 NCT07210658 on ClinicalTrials.gov ↗ ← All trials in the UK