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Studies

Interventional Recruiting

NCT07197814 on ClinicalTrials.gov

Evaluation of the Tolerance of a New Formula Based on Hydrolyzed Rice Proteins in Children With Cow's Milk Allergy

Official title: Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins in Children With IgE-mediated Cow's Milk Allergy

  • Sponsor: Health and Happiness Research Limited
  • Collaborators: Federico II University
  • Enrollment: 29 (Estimated)
  • Study start: 2026-01-23 (Actual)
  • Primary completion: 2026-10-01 (Estimated)
  • Study completion: 2026-12-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Crossover
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Other

Brief 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.

Conditions

  • IgE-Mediated Cow Milk Allergy

Intervention / Treatment

  • Other: Rice formula (New formula based on hydrolysed rice proteins)
  • Other: Placebo formula

Primary Outcome Measures

  • Hypoallergenicity of the Rice formula (At the end of the 7-day open feeding period)
    It will be assessed through the absence of medically confirmed allergic reaction to the study formula (Rice formula), based on assessment of clinical signs and symptoms at clinical DBPCFC testing and during the 7-day open feeding period.

Countries

Italy

Locations and Investigators

  • Federico II, University of Naples, Department of Translational Medical Science, Naples, Italy (Recruiting)