Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With C… (NCT07197814) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy
Italy29 participantsStarted 2026-01-23
Plain-language summary
The goal of this clinical trial is to see if a new formula based on hydrolysed rice proteins (Rice formula) is well tolerated by infants and young children with cow's milk allergy. In case the Rice formula is well tolerated, the formula will be considered " hypoallergenic ".
The main question it aims to answer is: Does the Rice formula cause allergic reactions in infants and young children who are allergic to cow's milk? Researchers will compare during a double-blind placebo-controlled food challenge (DBPCFC) the Rice formula to a Placebo formula to see if any allergic symptom appears after feeding with the Rice formula. If children do not show any allergic symptoms during the DBPCFC, they will then be exclusively formula-fed the Rice formula for 7 days.
Participants will:
* come at the hospital twice (around 7 days apart) for the DBPCFC
* then, after this procedure, be fed the Rice formula for 7 days, as a replacement for their usual infant formula
Their parents will pay attention to the appearance of any allergic symptom after each day of the DBPCFC, and during the 7-day feeding period. They will keep a diary of any adverse event in their child, the use of any concomitant treatment, and the introduction in their child's diet of any new allergenic food. In addition, during the 7-day feeding period, they will report quantities of the Rice formula consumed, data on regurgitations/vomiting if any, stool consistency/frequency/colour and their satisfaction.
Who can participate
Age range
1 Month – 36 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:
* Infants and young children between 1 and 36 months of age
* Consuming at least 240 ml/day of formula
* Gestational age ≥ 37 weeks
* Diagnosis of IgE-mediated CMA confirmed through a DBPCFC performed within 3 months prior to the enrolment
* Stable clinical condition and free from any symptoms possibly related to CMA for at least ≥4 weeks prior to recruitment
* Observing a strict cow's milk proteins elimination diet for at least 4 weeks prior to study enrollment
* Parents or legal guardians agree not to enroll infant in another interventional clinical study while participating in this study
* Written informed consent form obtained from both parents (or legally acceptable representative \[LAR\], if applicable)
* Infant's parents / LAR are of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol.
* Signed authorization obtained from both parents or legal guardian to use and/or disclose Protected Health Information for infant from birth through the length of the study period
Exclusion Criteria:
* Infant is exclusively breastfed.
* Any chronic diseases, chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
* Major gastrointestinal disease/abnormalities (other than CMA).
* Other food allergies
* Eosinophilic disorders of the gastrointestinal tract.
* Eviden…
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
Hypoallergenicity of the Rice formula
Timeframe: At the end of the 7-day open feeding period