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

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 10, 2018

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Gastrointestinal tolerance
    • Time Frame: Day 7 from baseline
    • 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
    • Time Frame: Day 7 from baseline
    • Volume of test product prescribed versus actually taken

Secondary Measures

  • Body weight
    • Time Frame: Day 7 from baseline
    • Weight will be measured in Kg

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nestlé
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Sharan Saduera, BSc, 07557170649, sharan.saduera@uk.nestle.com

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