Vegetarian Tube Feed Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: paediatric tube feed.
- Who it may be relevant to
- Registry conditions: Paediatric. Basic parameters: 1 year — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acceptability (Including Gastrointestinal Tolerance, Compliance) of a Vegetarian Paediatric Enteral Tube Feed With Food Derived Ingredients.
Overview
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 supplement paediatric tube feed
500ml tube feed to be provided daily over 28 days.
Primary outcome measures
- Gastrointestinal tolerance and formula intake [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07378111 · CPV tube feed PB002 · IRAS ID 341165