A Single Arm Intervention Study to Assess the Acceptability, Tolerance and Ease of Use of Wilbo's… (NCT07036081) | Clinical Trial Compass
CompletedNot Applicable
A Single Arm Intervention Study to Assess the Acceptability, Tolerance and Ease of Use of Wilbo's Blends+ (Commercial Enteral Feed Based on Real Food) When Used as Part of a Dietitian Prescribed Enteral Feeding Plan
United Kingdom45 participantsStarted 2025-10-16
Plain-language summary
The goal of this observational study is to learn if tube-fed children and young people (age 3-15 years) find Wilbo's Blends+ (a new nutritionally complete enteral formula containing real food ingredients) acceptable, tolerable and easy to use. The main question it aims to answer is:
Is Wilbo's Blends+ acceptable when included in the feeding plan of tube-fed children and young people (age 3-15 years)
Participants will:
Take Wilbo's Blend+ for a 7 day period as part of their feeding plan Complete questionnaires about their gastrointestinal symptoms
Who can participate
Age range
3 Years – 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
* Children and young people (age 3-15) who are assessed by a Doctor or Dietitian as requiring enteral tube feeding via gastrostomy.
* Children and young people able to receive a minimum of 30% of their daily intake from the study product for at least 7 consecutive days.
* Participant is capable of communication/filling in the questionnaires or having a parent/carer who can answer the questions by close observation of the participant reactions. If there are any communication issues the research dietitian/nurse should support. Written, informed consent from the parent/carer/guardian and assent from the participant obtained.
Exclusion Criteria:
* \<3 years old
* \>15 years old
* Total Parenteral Nutrition
* Post pyloric enteral feeding
* Enteral tube feeding via Nasogastric tube
* Patients with severe renal, oncology, metabolic, IBD or hepatic conditions who are considered clinically unstable
* Known food allergies or intolerances to any ingredient in the product
* Requirement of a fibre free feed (e.g. IBD)
* Children who had an inability to comply with the study protocol, in the opinion of the investigator
* Children who have been involved in another interventional study within 2 weeks of this study.
* Children with recent changes (within 1 week) in medication used to manage gastrointestinal symptoms
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
1
Acceptability with regard to gastrointestinal tolerance