Acceptability, Gastro Intestinal Tolerance Compliance of a Paediatric Tube-feed Formula Derived From Food for Children

Not Applicable

Completed

• Conditions: Child Nutrition Disorders
• Interventions: Other: Pediatric Formula

• Registration Number: NCT03718195
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study Start: 2018-08-21
• Study First Submitted: 2018-08-22
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-24
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Last Update Submitted: 2020-08-17
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric formula	Pediatric Formula	Each child will receive a new formula for a period of seven days. The new formula is a nutritionally complete standard enteral tube feed, with ingredients derived from real food. The formula is a food for special medical purposes for use under medical supervision. The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube

Primary Outcome Measures

Name	Time	Method
Participant compliance	Day 7 from baseline	Volume of test product prescribed versus actually taken
Gastrointestinal tolerance	Day 7 from baseline	Incidence of gastrointestinal adverse effects. Tolerance will be evaluated on the basis of the number of gastrointestinal events including diarrhea, constipation, bloating, distension, nausea, vomiting, burping, flatulence and regurgitation and abdominal discomfort or pain reported for subjects during their participation in the study.

Secondary Outcome Measures

Name	Time	Method
Body Weight	Day 7 from baseline	Weight will be measured in Kg

Trial Locations

Locations (3)

Evelina Childrens Hospital; 🇬🇧 London, United Kingdom

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom

East Oxford Health Centre; 🇬🇧 Oxford, United Kingdom