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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	1 Month - 36 Months
Gender	All

More Inclusion & Exclusion Criteria

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.

- Evidence of non-IgE-mediated CMA.

- Immunodeficiency.

- Use of drugs that may interfere with the interpretation and safety of the SPT procedure planned on Inclusion visit such as antihistamines and topical corticosteroids in the previous week, angiotensin-converting enzyme (ACE) inhibitors within the 2 days before or beta-blockers the day before as well as skin moisturizers used on the skin where solution drops will be applied.

- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07197814
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Health and Happiness Research Limited
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Not yet recruiting
Countries	Italy
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	IgE-Mediated Cow Milk Allergy

Arms & Interventions

Arms

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

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.

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

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.

Interventions

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

Infant formula based on hydrolysed rice proteins.

Other: - Placebo formula

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.

Contact a Trial Team

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International Sites

Napoli 9031661, Italy

Status

Address

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

Napoli 9031661, ,

Site Contact

Roberto Berni Canani, Professor

[email protected]

0039 0817462680

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