CompletedNot Applicable

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

United Kingdom15 participantsStarted 2018-08-08

Plain-language 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).

Who can participate

Age range1 Year – 15 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Gastrointestinal tolerance

Timeframe: Day 7 from baseline

Participant compliance

Timeframe: Day 7 from baseline

Trial details

NCT IDNCT03718208

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-07-22