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Oral Immunotherapy Using Partially Hydrolyzed Formula for Cow's Milk Protein Allergy: A Randomized, Controlled Trial
Chisato Inuo1,2,3, Kenichi Tanaka2, Satoko Suzuki2
1Department of Pediatrics, School of Medicine, Fujita Health University, Toyoake, Japan.
Insights
Partially hydrolyzed formula (pHF) safely enhanced tolerance to cow's milk protein allergy (CMPA) in children. This oral immunotherapy approach, using pHF, showed improved thresholds compared to extensively hydrolyzed formula (eHF).
Area of Science:
- Pediatric Allergy and Immunology
- Gastroenterology
- Immunology
Background:
- Cow's milk protein allergy (CMPA) affects many children, often necessitating specialized formulas.
- Partially hydrolyzed formula (pHF) exhibits reduced allergenicity, making it a candidate for oral immunotherapy (OIT).
- Investigating the safety and efficacy of pHF-based OIT is crucial for managing CMPA.
Purpose of the Study:
- To evaluate the efficacy and safety of oral immunotherapy using partially hydrolyzed formula (pHF) in children diagnosed with CMPA.
- To compare the effects of pHF-based OIT with extensively hydrolyzed formula (eHF) in CMPA management.
Main Methods:
- A randomized, double-blind, controlled trial involving 25 children aged 1-9 years with CMPA.
- Participants were assigned to either a pHF-pHF group or an eHF-pHF group for initial treatment, followed by an open-label phase with pHF for all.
- Primary endpoint: change in allergen threshold post-initial phase. Secondary endpoints: changes in thresholds, casein-specific IgE, IgG4, and basophil activation.
Main Results:
- The pHF-pHF group demonstrated a significant elevation in allergen threshold (p = 0.048) after the initial phase, unlike the eHF-pHF group.
- No significant changes in thresholds were observed between other phases in either group.
- The eHF-pHF group showed a significant decrease in casein-specific IgE levels (p = 0.014). No severe allergic reactions occurred.
Conclusions:
- Partially hydrolyzed formula (pHF) may be a safe and effective option for enhancing tolerance in children with CMPA.
- pHF-based oral immunotherapy appears to be a viable alternative to eHF for improving cow's milk tolerance.
- The study supports the use of pHF in OIT protocols for pediatric CMPA.
Background:
Partially hydrolyzed cow's milk protein-based formula (pHF) possesses low allergenicity. Here, we investigate the safety and efficacy of oral immunotherapy using pHF for children with cow's milk protein allergy (CMPA).
Objectives:
A randomized, double-blind, controlled single-center trial was conducted to evaluate the efficacy and safety of pHF oral immunotherapy in children with CMPA.
Methods:
Participants were randomized into double-blind pHF-pHF and extensively hydrolyzed cow's milk protein-based formula (eHF)-pHF groups. During this phase, the pHF-pHF group received pHF and the eHF-pHF group received eHF. During the open phase, all participants received pHF. The primary end point was a change in thresholds between baseline and the end of the first phase. Secondary end points were changes in thresholds between baseline and the end of the second phase, and casein-specific immunoglobulin (Ig)E, IgG4, and basophil activation.
Results:
Twenty-five children, aged 1-9 years, were randomized into pHF-pHF and eHF-pHF groups. The threshold between baseline and the end of the first phase was significantly elevated in the pHF-pHF group (p = 0.048), but not in the eHF-pHF group. The threshold between other phases did not change significantly in either group. There were significant decreases in casein-specific IgE antibody levels between baseline and the second phase in the eHF-pHF group (p = 0.014). No participants suffered systemic allergic reactions requiring adrenaline or systemic corticosteroids after receiving the formulas.
Conclusions:
The results of this trial suggest that, in children with CMPA, tolerance to cow's milk might be safely enhanced by intake of pHF, relative to that of eHF.
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