Clinical trial NCT03718208: Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.
Official title: To Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Low Calorie Peptide Based Paediatric Tube-feed Formula; for Children Greater Than 1 Year of Age.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of a low calorie paediatric peptide based tube feed formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae;

The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Detailed description: Patients well established and stable on a standard or peptide enteral tube feed will be changed to a low calorie paediatric formula for a period of seven days. This group will act as their own controls. Each child will receive for a period of seven days the paediatric formula.

The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. A baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms and weight at the start of the study.

The parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.

Eligibility criteria: Inclusion Criteria:

* Exclusively tube fed
* Paediatrics aged 1 year above who require a low calorie feed
* Children with Neurological impairment (NI) who require long term tube feeding
* Patients established on a standard or peptide Enteral formula (no gastrointestinal intolerances on a current formula)
* Willingly given, written, informed consent from patient or parent/guardian.
* Willingly given, written assent (if appropriate).

Exclusion Criteria:

* Inability to comply with the study protocol, in the opinion of the investigator
* Known food allergies to any ingredients (see ingredients list)
* Patients with significant renal or hepatic impairment
* Participation in another interventional study within 2 weeks of this study.

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: Day 7 from baseline
measure: Participant compliance
timeFrame: Day 7 from baseline
Secondary outcomes:
measure: Body weight
timeFrame: Day 7 from baseline
Other outcomes:
Locations:
city: Amersham
country: United Kingdom
facility: Waldron Health Centre
city: Brighton
country: United Kingdom
facility: Alexandra Children's Hospital
city: Manchester
country: United Kingdom
facility: Gorton Clinic
Study officials:
affiliation: Dietitian
name: Clare Thornton-Wood, BSc
role: PRINCIPAL_INVESTIGATOR
References: