Clinical trial NCT03718195: Acceptability, Gastro Intestinal Tolerance Compliance of a Paediatric Tube-feed Formula Derived From Food for Children
Official title: Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Paediatric Tube-feed Formula Ingredients Derived From Real Food for Children Over 12 Months of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Nutrition Disorders
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-10-24
Enrollment: 19
Sex: FEMALE
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of pediatric 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; feeding intolerances, developmental disabilities, disease related malnutrition 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 enteral tube feed will be changed to a 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, a nutritionally complete standard enteral tube feed.

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, current oral intake 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

* Require a tube feed (taking \>75% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
* Paediatrics aged 1 year above.
* Patients well established and stable on a standard or peptide enteral formula (no gastrointestinal intolerances on 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
* Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
* 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: London
country: United Kingdom
facility: Evelina Childrens Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: Oxford
country: United Kingdom
facility: East Oxford Health Centre
Study officials:
affiliation: Dietitian
name: Clare Thornton-Wood, BSc
role: PRINCIPAL_INVESTIGATOR
References: