Childrens Real Food Tolerance Study (NCT05269992) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Childrens Real Food Tolerance Study
United Kingdom60 participantsStarted 2022-05-01
Plain-language summary
A prospective, longitudinal, 28-day intervention study evaluating the tolerance, compliance, acceptability and safety to two new enteral tube feed and one new oral nutritional supplement based on real food ingredients (1kcal/ml and 1.5kcal/ml enteral tube feeds and a 1.5kcal/ml oral nutritional supplement).
Who can participate
Age range
1 Year – 16 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:
* Children from 1 year to 16 years of age.
* Requiring oral or enteral nutritional support from a whole protein 1kcal/ml or a 1.5kcal/ml enteral tube feed (via an existing enteral feeding tube) or oral nutritional supplement for at least 28 days.
* Expected to receive a minimum of 300kcal/day from the study product(s).
* Informed consent obtained from the patient/carer.
Exclusion Criteria:
* Total parenteral nutrition (100% of requirements).
* Allergy to any of the study product ingredients.
* Severe galactose (galactosaemia) or lactose intolerance.
* Severe hepatic, metabolic or renal dysfunction.
* Requirement for a fibre free feed.
* Requirement for a hydrolysed, elemental or any other specialised feed.
* On high intensity chemotherapy or radiation therapy, pancreatitis, chylothorax, or Inflammatory Bowel Disease.
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.