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NCT Number: NCT03718208

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

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).

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Waldron Health Centre, Amersham, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  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

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.

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.

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