Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.
ConditionPaediatrics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-16
SponsorSociété des Produits Nestlé (SPN)
About this trial
Acceptability, compliance and palatability study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients from 1-15 years requiring 1 or more oral nutritional supplement to replace current oral nutritional supplement 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
Unsafe swallow
Inability to comply with the study protocol, in the opinion of the investigator.
Under 1 years of age
Patients on total parenteral nutrition
Trial design
Design model
Single group
Treatments tested in this trial
Oral nutritional supplementation
Dietary supplementAs directed by the HCP
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Children will act as their own control for the nutritional productOther 1 intervention
Trial outcomes
Primary outcomes
1
Gastrointestinal tolerance
Number of children who experienced gastrointestinal symptoms such as reflux, vomiting, nausea, constipation, diarrhoea recorded as a 4 point Likert scale as none, mild, moderate, severe symptoms at baseline and at post switch.
Time frame
Days 1-7, and at day 14, 21 and 28Secondary outcomes
1
Formula intake in mLs
The amount of mLs of formula intake by patient compared to what was prescribed in mLs.
Time frame
28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov