Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorSociété des Produits Nestlé (SPN)
About this trial
This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants.
The enteral bolus formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients from 1 -15 years for children and 15 years and above for adults of requiring 1 or more bolus tube feed alongside their usual tube feed or home-made blended diet as part of their dietary management for disease related malnutrition.
Patients well-established and stable on current enteral tube feed or home-made blended diet.
Gastrostomy fed only.
Willingly given, written, informed consent from patient/caregiver
Disqualifiers
Inability to comply with the study protocol, in the opinion of the investigator.
Under 1 years of age
Patients who have a nasogastric and jejunal feeding tubes
Patients on total parenteral nutrition
Trial design
Design model
Single group
Treatments tested in this trial
Tube feed
Dietary supplementDose intake and duration.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Acceptability and Tolerance Study of bolus tube feed with food blendsOther 1 intervention
Trial outcomes
Primary outcomes
1
Measure of Gastrointestinal tolerance
Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe).
Time frame
7 days2
Daily record of formula intake.
Measure of formula intake in mL.
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov