Vegetarian Tube Feed Study (Tube feed)

March 11, 2026 updated by: Société des Produits Nestlé (SPN)

Acceptability (Including Gastrointestinal Tolerance, Compliance) of a Vegetarian Paediatric Enteral Tube Feed With Food Derived Ingredients.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Acceptability (including gastrointestinal tolerance, compliance of a paediatric vegetarian tube feed with food derived ingredients. Gastrointestinal tolerance will data will be collected using a 4point Likert scale, daily record of tube feed volume intake.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children will act as their own control for the nutritional product
Gastrointestinal tolerance and daily formula intake over 28 days.
Dietary supplement: paediatric tube feed
500ml tube feed to be provided daily over 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastrointestinal tolerance and formula intake
Time Frame: From enrolment to end of study over 28 days
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
Time Frame: From enrolment to end of study over 28 days
Formula intake measured daily in mLs over 28 days.
From enrolment to end of study over 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Dr Graeme O'Connor, PHD, Great Ormond Street Hospital Nutrition and Dietetics Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

September 7, 2026

Study Completion (Estimated)

December 22, 2026

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 26, 2026

First Posted (Actual)

January 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CPV tube feed PB002
  • IRAS ID 341165 (Other Identifier: Yorkshire & The Humber - South Yorkshire Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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