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Acceptability, Gastro Intestinal Tolerance Compliance of a Paediatric Tube-feed Formula Derived From Food for Children

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ClinicalTrials.gov Identifier: NCT03718195
Recruitment Status : Completed
First Posted : October 24, 2018
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Nestlé

Study Description
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Brief Summary:
This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of pediatric 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; feeding intolerances, developmental disabilities, disease related malnutrition The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Condition or disease Intervention/treatment Phase
Child Nutrition Disorders Other: Pediatric Formula Not Applicable

Detailed Description:

Patients well established and stable on a standard enteral tube feed will be changed to a 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, a nutritionally complete standard enteral tube feed.

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, current oral intake 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluate the Acceptability (Including Gastro Intestinal Tolerance and Compliance) of a Paediatric Tube-feed Formula Ingredients Derived From Real Food for Children Over 12 Months of Age
Actual Study Start Date : August 21, 2018
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Pediatric formula

Each child will receive a new formula for a period of seven days. The new formula is a nutritionally complete standard enteral tube feed, with ingredients derived from real food. 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

 Other: Pediatric Formula
One week intake diary, one week tolerance diary, product intake


Outcome Measures
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Primary Outcome Measures :
  1. Gastrointestinal tolerance [ Time Frame: Day 7 from baseline ]
    Incidence of gastrointestinal adverse effects. 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.

  2. Participant compliance [ Time Frame: Day 7 from baseline ]
    Volume of test product prescribed versus actually taken


Secondary Outcome Measures :
  1. Body Weight [ Time Frame: Day 7 from baseline ]
    Weight will be measured in Kg


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Require a tube feed (taking >75% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
  • Paediatrics aged 1 year above.
  • Patients well established and stable on a standard or peptide enteral formula (no gastrointestinal intolerances on 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
  • Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
  • Participation in another interventional study within 2 weeks of this study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718195


Locations
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United Kingdom
Evelina Childrens Hospital
London, United Kingdom, SE1 7EH
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
East Oxford Health Centre
Oxford, United Kingdom, OX4 1XD
Sponsors and Collaborators
Nestlé
Investigators
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Principal Investigator: Clare Thornton-Wood, BSc Dietitian
More Information
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03718195    
Other Study ID Numbers: BLEND001
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nutrition Disorders
Child Nutrition Disorders