Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.

Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a Paediatric Oral Nutritional Supplement Containing Food Blends.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07210658

Enrollment

Registered

2025-10-07

Start date

2025-04-14

Completion date

2026-05-15

Last updated

2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatrics

Keywords

Acceptability

Brief summary

Acceptability, compliance and palatability study.

Detailed description

Acceptability (including gastrointestinal tolerance, compliance and palatability) of a paediatric oral nutritional supplement containing food blends.

Interventions

DIETARY_SUPPLEMENTOral nutritional supplementation

As directed by the HCP

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Intervention model description

Children will act as their own control.

Eligibility

Sex/Gender

ALL

Age

1 Years to 16 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Formula intake in mLs	28 days	The amount of mLs of formula intake by patient compared to what was prescribed in mLs.

Countries

United Kingdom

Contacts

Primary ContactSharan Saduera, BSc (Hons) Dietetics

sharan.saduera@uk.nestle.com+447557170649

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026