Vegetarian Tube Feed Study
ConditionPaediatric
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-15
SponsorSociété des Produits Nestlé (SPN)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
paediatric tube feed
Dietary supplement500ml tube feed to be provided daily over 28 days.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Children will act as their own control for the nutritional productExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gastrointestinal tolerance and formula intake
Daily gastrointestinal tolerance measured using a 4 point Likert scale of none, mild, moderate, severe symptoms over days.
Time frame
From enrolment to end of study over 28 days2
Formula volume intake in mL
Formula intake measured daily in mLs over 28 days.
Time frame
From enrolment to end of study over 28 daysLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: