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

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.

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).

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Dietary supplement: Paediatric Formula

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Amersham, United Kingdom, SE14 6LD
    • Waldron Health Centre
  • Brighton, United Kingdom, BN2 5BE
    • Alexandra Children's Hospital
  • Manchester, United Kingdom, M12 5JY
    • Gorton Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paediatric formula; 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.	Dietary supplement: Paediatric Formula; Children will switch over to the low calorie paediatric feed. Intake diaries and tolerance diaries will be completed for one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 7 from baseline
Participant compliance	Volume of test product prescribed versus actually taken	Day 7 from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body weight	Weight will be measured in Kg	Day 7 from baseline

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Clare Thornton-Wood, BSc, Dietitian

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Actual): July 22, 2019
• Study Completion (Actual): July 22, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: Low calorie 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No