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

NCT07197814 | Recruiting

• 1 other identifier: BST-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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

Keywords

Cow's milk allergy; Hydrolyzed rice proteins-based formula; IgE-mediated; Oral food challenge; Hypoallergenicity; Tolerance

Outcome Measures

Primary Outcomes (1)

• Hypoallergenicity of the Rice formula

  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.

  At the end of the 7-day open feeding period

Study Arms (2)

DBPCFC = Day 1: Rice formula; Day 2: Placebo formula

EXPERIMENTAL

On Day 1 of the DBPCFC, subjects will receive the Rice formula. On Day 2 of the DBPCFC, subjects will receive the Placebo formula. If subjects tolerate the Rice formula during this DBPCFC, they will then be fed the Rice formula for 7 days.

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

DBPCFC = Day 1: Placebo formula; Day 2: Rice formula

EXPERIMENTAL

On Day 1 of the DBPCFC, subjects will receive the Placebo formula. On Day 2 of the DBPCFC, subjects will receive the Rice formula. If subjects tolerate the Rice formula during this DBPCFC, they will then be fed the Rice formula for 7 days.

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

Interventions

Placebo formula OTHER

The placebo formula will be the formula the subject is currently successfully fed with as part of his/her diet to eliminate cow's milk proteins.

DBPCFC = Day 1: Placebo formula; Day 2: Rice formula; DBPCFC = Day 1: Rice formula; Day 2: Placebo formula

Rice formula (New formula based on hydrolysed rice proteins) OTHER

Infant formula based on hydrolysed rice proteins.

DBPCFC = Day 1: Placebo formula; Day 2: Rice formula; DBPCFC = Day 1: Rice formula; Day 2: Placebo formula

Eligibility Criteria

• Age: 1 Month - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Evidence of non-IgE-mediated CMA.
• Immunodeficiency.
• Previous use of systemic immunomodulatory treatment at any time before study entry.
• Use of systemic antibiotics or anti-mycotic drugs within 4 weeks before study entry.
• Persistent wheeze or chronic respiratory disease.
• Severe uncontrolled eczema.
• Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment.
• Infant's parents/LAR have medical or psychiatric condition that, in the judgement of the Investigator, would make the subject inappropriate for entry into the study.

Sponsors & Collaborators

• Health and Happiness Research Limited: lead
• Federico II University: collaborator

Study Sites (1)

Federico II, University of Naples, Department of Translational Medical Science

Naples, Italy

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: September 29, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

IT (1)