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

Primary Purpose

Child Nutrition Disorders

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Pediatric Formula

About this trial

This is an interventional health services research trial for Child Nutrition Disorders

Eligibility Criteria

1 Year - 15 Years (Child)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Evelina Childrens Hospital
Chelsea and Westminster Hospital
East Oxford Health Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pediatric formula

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Participant compliance

Volume of test product prescribed versus actually taken

Secondary Outcome Measures

Body Weight

Weight will be measured in Kg

Full Information

NCT ID

NCT03718195

First Posted

August 22, 2018

Last Updated

August 17, 2020

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT03718195

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 21, 2018 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Child Nutrition Disorders

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pediatric formula

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Pediatric Formula

Intervention Description

One week intake diary, one week tolerance diary, product intake

Primary Outcome Measure Information:

Title

Gastrointestinal tolerance

Description

Time Frame

Day 7 from baseline

Title

Participant compliance

Description

Volume of test product prescribed versus actually taken

Time Frame

Day 7 from baseline

Secondary Outcome Measure Information:

Title

Body Weight

Description

Weight will be measured in Kg

Time Frame

Day 7 from baseline

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clare Thornton-Wood, BSc

Organizational Affiliation

Dietitian

Official's Role

Principal Investigator

Facility Information:

Facility Name

Evelina Childrens Hospital

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Chelsea and Westminster Hospital

City

London

ZIP/Postal Code

SW10 9NH

Country

United Kingdom

Facility Name

East Oxford Health Centre

City

Oxford

ZIP/Postal Code

OX4 1XD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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