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

Cerebral Palsy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718208
• Other study ID #: Low calorie 001
• Status: Completed
• Phase: N/A
• Start date: August 8, 2018
• Est. completion date: July 22, 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 22, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Waldron Health Centre	Amersham
United Kingdom	Alexandra Children's Hospital	Brighton
United Kingdom	Gorton Clinic	Manchester

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 [ 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
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