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

NCT03718208 | Completed

• 1 other identifier: Low calorie 001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

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).

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Body weight

  Day 7 from baseline

Study Arms (1)

Paediatric formula

EXPERIMENTAL

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

Interventions

Paediatric Formula DIETARY_SUPPLEMENT

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

Paediatric formula

Eligibility Criteria

• Age: 1 Year - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (3)

Waldron Health Centre

Amersham, SE14 6LD, United Kingdom

Location

Alexandra Children's Hospital

Brighton, BN2 5BE, United Kingdom

Location

Gorton Clinic

Manchester, M12 5JY, United Kingdom

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Clare Thornton-Wood, BSc

  Dietitian

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: October 24, 2018
• Study Start: August 8, 2018
• Primary Completion: July 22, 2019
• Study Completion: July 22, 2019
• Last Updated: August 19, 2020

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: The study has been published in a journal
• Access Criteria: Avaliable on the internet

Locations

GB (3)