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 range

1 Year – 15 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Cerebral Palsy trials