NCT07378111

Brief Summary

This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients.

Trial Health

65
Monitor

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
8mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

January 8, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

January 8, 2026

Last Update Submit

March 11, 2026

Conditions

Paediatric

Outcome Measures

Primary Outcomes (2)

  • Gastrointestinal tolerance and formula intake

    Daily gastrointestinal tolerance measured using a 4 point Likert scale of none, mild, moderate, severe symptoms over days.

    From enrolment to end of study over 28 days

  • Formula volume intake in mL

    Formula intake measured daily in mLs over 28 days.

    From enrolment to end of study over 28 days

Study Arms (1)

Children will act as their own control for the nutritional product

EXPERIMENTAL

Gastrointestinal tolerance and daily formula intake over 28 days.

Dietary Supplement: paediatric tube feed

Interventions

paediatric tube feedDIETARY_SUPPLEMENT

500ml tube feed to be provided daily over 28 days.

Children will act as their own control for the nutritional product

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients from 1 -15 years requiring more than 50% of energy from tube feeding or to take alongside home-made blended diet 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:

  • No established tube feed.
  • Inability to comply with the study protocol, in the opinion of the investigator.
  • Under 1 years of age
  • Patients on parenteral nutrition
  • Known food allergies, including to any ingredients listed in appendix 1.
  • 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 Officials

  • Dr Graeme O'Connor, PHD

    Great Ormond Street Hospital Nutrition and Dietetics Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharan BSc (hons), Nutrition and 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 30, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

September 7, 2026

Study Completion (Estimated)

December 22, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share