Cerebral Palsy (CP), Oncology
Conditions
Brief summary
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.
Detailed description
The study will collect data in 50 children and adults over a period of 28 days. Gastrointestinal tolerance will be collected over 7 days and formula intake will be over 28 days. A patient satisfaction questionnaire will be completed at the end of the study.
Interventions
DIETARY_SUPPLEMENTTube feed
Dose intake and duration.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Known food allergies to any ingredients listed in appendix 1. * Patients with significant renal or hepatic impairment * Participation in another interventional study within 2 weeks of this study. * Patients with known or suspected ileus or mechanical bowel obstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Gastrointestinal tolerance | 7 days | Severity of symptoms such as reflux, vomiting, constipation, diarrhoea as a four-point likert scale (none, mild, moderate, severe). |
| Daily record of formula intake. | 28 days | Measure of formula intake in mL. |
Countries
United Kingdom
Contacts
Primary ContactSharan Saduera, BSc (Hons) Dietetics
Backup ContactSarah Durnan, PHD, BSc Nutrition Dietetics
Outcome results
None listed