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

Child Nutrition Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718195
• Other study ID #: BLEND001
• Status: Completed
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: October 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 1 Year to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Nutrition Disorders

Intervention

Other:
• Pediatric Formula
One week intake diary, one week tolerance diary, product intake

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	Evelina Childrens Hospital	London
United Kingdom	East Oxford Health Centre	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal tolerance	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.	Day 7 from baseline
Primary	Participant compliance	Volume of test product prescribed versus actually taken	Day 7 from baseline
Secondary	Body Weight	Weight will be measured in Kg	Day 7 from baseline