Skip to main content
OpenTrials
Completed

NCT Number: NCT03718195

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year–15 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chelsea and Westminster Hospital, London, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Formula

Other

One week intake diary, one week tolerance diary, product intake

Primary outcomes

  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 outcomes

  1. Body Weight

    Time frame: Day 7 from baseline

    Weight will be measured in Kg

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2018
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.