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The purpose of the study is to determine whether a new hydrolyzed rice protein-based formula is hypoallergenic in infants and young children with documented Immunoglobulin E (IgE)-mediated Cow Milk Protein Allergy (CMPA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental formula-Control formula | Other | Blinded cross-over oral food challenge sequence starting by Experimental formula followed by Control. Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days. |
|
| Control formula-Experimental formula | Other | Blinded cross-over oral food challenge sequence starting by Control followed by Experimental formula. Following the crossover phase, children who passed the oral food challenge will consume the open label experimental formula at home during 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental formula | Other | New hydrolyzed rice protein-based formula |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoallergenicity of a Hydrolyzed Rice Protein-based Formula (Experimental Formula) | by measuring the proportion of participants who "passed" the food challenge test, meaning who consumed all doses and exhibited no allergic reactions to any of the doses of the experimental formula. | during test day |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance of experimental formula during at home consumption period | by evaluating gastrointestinal symptoms, using information recorded by parents daily in a diary | during 7 days |
| Safety of experimental formula during the at-home consumption |
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Inclusion criteria:
Exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin Klinik für Pädiatrie m.S. Pneumologie/Immunologie | Berlin | Germany | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42099766 | Derived | Zemrani B, Hays NP, D'Auria E, Mori F, Kalb B, Darwish N, Esposito S, Brzozowska A, Jedynak-Wasowicz U, Beyer K, Szajewska H, Canani RB. Hypoallergenicity of a hydrolyzed rice protein-based formula containing 2-fucosyllactose and lacto-N-neotetraose in children with cow's milk allergy: protocol for a randomized controlled study. The RIGHT-HY study. Front Nutr. 2026 Apr 22;13:1798624. doi: 10.3389/fnut.2026.1798624. eCollection 2026. |
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| Control formula | Other | Commercially available amino acid-based formula. |
|
By assessing the frequency and severity of adverse events reported by parents during the home usage phase |
| during 7 days |
| IRCCS Azienda Ospedaliero Universitaria Meyer Viale Gaetano Pieraccini |
| Florence |
| Italy |
| Ospedale dei Bambini V. Buzzi Via Castelvetro, 32 | Milan | 20154 | Italy |
| Universiy of Naples Federico II | Naples | Italy |
| Azienda Ospedaliero Universitaria di Parma, Italy | Parma | Italy |
| Nicolaus Copernicus University in Torun | Bydgoszcz | Poland |
| Centrum Medyczne Plejady | Krakow | Poland |
| Jagiellonian University Medical College | Krakow | Poland |
| Wojewodzki Szpital Specjalistyczny im. M. Kopernika | Lodz | Poland |
| BioMedical Centers sp. z o.o. | Warsaw | 02-595 | Poland |
| Pediatrics Department at the Medical University of Warsaw | Warsaw | Poland |
| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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