Vegetarian Tube Feed Study

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07378111

Acronym

Tube feed

Enrollment

Registered

2026-01-30

Start date

2026-03-30

Completion date

2026-12-22

Last updated

2026-03-12

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

Conditions

Paediatric

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.

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.

Interventions

DIETARY_SUPPLEMENTpaediatric tube feed

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Gastrointestinal tolerance and formula intake	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.
Formula volume intake in mL	From enrolment to end of study over 28 days	Formula intake measured daily in mLs over 28 days.

Contacts

CONTACTSharan BSc (hons), Nutrition and Dietetics

sharan.saduera@uk.nestle.com+447557170649

PRINCIPAL_INVESTIGATORDr Graeme O'Connor, PHD

Great Ormond Street Hospital Nutrition and Dietetics Department

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026