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Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Paediatric Formula

About this trial

This is an interventional other trial for Cerebral Palsy

Eligibility Criteria

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

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.

Sites / Locations

Waldron Health Centre
Alexandra Children's Hospital
Gorton Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paediatric formula

Arm Description

Each child will receive for a period of seven days. 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. One week intake diary, one week tolerance diary, product intake.

Outcomes

Primary Outcome Measures

Gastrointestinal tolerance

Incidence of gastrointestinal adverse effects [ Time Frame: day 7 from baseline ]. 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. nausea, vomiting. burping, flatulence and regurgitation and abdominal discomfort or pain

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

NCT03718208

First Posted

August 22, 2018

Last Updated

August 17, 2020

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT03718208

Brief Title

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

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

August 8, 2018 (Actual)

Primary Completion Date

July 22, 2019 (Actual)

Study Completion Date

July 22, 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 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.

6. Conditions and Keywords

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

Cerebral Palsy

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paediatric formula

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Paediatric Formula

Intervention Description

Children will switch over to the low calorie paediatric feed. Intake diaries and tolerance diaries will be completed for one week.

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

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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.

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

Waldron Health Centre

City

Amersham

ZIP/Postal Code

SE14 6LD

Country

United Kingdom

Facility Name

Alexandra Children's Hospital

City

Brighton

ZIP/Postal Code

BN2 5BE

Country

United Kingdom

Facility Name

Gorton Clinic

City

Manchester

ZIP/Postal Code

M12 5JY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Yes see details below

IPD Sharing Time Frame

The study has been published in a journal

IPD Sharing Access Criteria

Avaliable on the internet

IPD Sharing URL

https://www.heraldopenaccess.us/openaccess/tolerance-and-acceptability-of-a-low-calorie-paediatric-peptide-enteral-tube-formula-a-multicentre-trial-in-the-united-kingdom

Learn more about this trial

Acceptability and Tolerance Study of a Low Calorie Peptide Based Paediatric Tube Feed Formula.

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