NCT07210658

Brief Summary

Acceptability, compliance and palatability study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
0mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Apr 2025May 2026

Study Start

First participant enrolled

April 14, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Expected
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

July 23, 2025

Last Update Submit

January 8, 2026

Conditions

Paediatrics

Keywords

Acceptability

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal tolerance

    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.

    Days 1-7, and at day 14, 21 and 28

Secondary Outcomes (1)

  • Formula intake in mLs

    28 days

Study Arms (1)

Children will act as their own control for the nutritional product

OTHER
Dietary Supplement: Oral nutritional supplementation

Interventions

Oral nutritional supplementationDIETARY_SUPPLEMENT

As directed by the HCP

Children will act as their own control for the nutritional product

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dietetics

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Sharan Saduera, BSc (Hons) Dietetics

CONTACT

+447557170649sharan.saduera@uk.nestle.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Children will act as their own control.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

October 7, 2025

Study Start

April 14, 2025

Primary Completion

November 10, 2025

Study Completion (Estimated)

May 15, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations

GB(1)