Hydrolysed Rice Formula Study (NCT06288503) | Clinical Trial Compass
RecruitingNot Applicable
Hydrolysed Rice Formula Study
United Kingdom86 participantsStarted 2024-02-01
Plain-language summary
This non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. The primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental QOL, acceptability, dietary intake, and safety.
Who can participate
Age range
0 Months – 13 Months
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:
* Male or female
* Aged 0-13 months
* Presenting to primary or secondary care with symptoms/clinical history suggestive of CMA
* Will receive at least 30% of energy requirements from the study formula
* Written informed consent from parent/carer
Exclusion Criteria:
* Severe CMA (including anaphylaxis) and/or requiring an AAF
* Faltering growth (based on NICE guidelines36 - Appendix 1)
* Previous allergy to any study product ingredients (including whey hydrolysate and/or rice)
* Primary lactose intolerance
* Food Protein-Induced Enterocolitis Syndrome (FPIES)
* Exclusively breast fed
* Severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes
* Severe hepatic or renal insufficiency
* Premature infants (born \<37 weeks) with a corrected age of \<4 weeks
* Requirement for any parenteral nutrition
* Participation in other clinical intervention studies within 1 month of recruitment
* Concern around the willingness/ability of the caregiver to comply with the study protocol and/or study requirements
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.