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NCT Number: NCT07378111

Vegetarian Tube Feed Study

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.

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Key information

Conditions

Paediatric

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paediatric tube feed

Dietary Supplement

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

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sharan BSc (hons), Nutrition and Dietetics

CONTACT

[email protected]

+447557170649

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Acronym: Tube feed

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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