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Oral Immunotherapy Using Partially Hydrolyzed Formula for Cow's Milk Protein Allergy: A Randomized, Controlled Trial.
Int Arch Allergy Immunol. 2018; 177(3):259-268.IA

Abstract

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.

Authors+Show Affiliations

Department of Pediatrics, School of Medicine, Fujita Health University, Toyoake, Japan. Department of Pediatrics, Second Teaching Hospital, Fujita Health University, Nagoya, Japan. Department of Allergy, Kanagawa Children's Medical Center, Yokohama, Japan.Department of Pediatrics, Second Teaching Hospital, Fujita Health University, Nagoya, Japan.Department of Pediatrics, Second Teaching Hospital, Fujita Health University, Nagoya, Japan.Department of Pediatrics, School of Medicine, Fujita Health University, Toyoake, Japan.Department of Pediatrics, Second Teaching Hospital, Fujita Health University, Nagoya, Japan.Department of Pediatrics, School of Medicine, Fujita Health University, Toyoake, Japan.Department of Pediatrics, Second Teaching Hospital, Fujita Health University, Nagoya, Japan.Department of Pediatrics, Second Teaching Hospital, Fujita Health University, Nagoya, Japan.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

30134240

Citation

Inuo, Chisato, et al. "Oral Immunotherapy Using Partially Hydrolyzed Formula for Cow's Milk Protein Allergy: a Randomized, Controlled Trial." International Archives of Allergy and Immunology, vol. 177, no. 3, 2018, pp. 259-268.
Inuo C, Tanaka K, Suzuki S, et al. Oral Immunotherapy Using Partially Hydrolyzed Formula for Cow's Milk Protein Allergy: A Randomized, Controlled Trial. Int Arch Allergy Immunol. 2018;177(3):259-268.
Inuo, C., Tanaka, K., Suzuki, S., Nakajima, Y., Yamawaki, K., Tsuge, I., Urisu, A., & Kondo, Y. (2018). Oral Immunotherapy Using Partially Hydrolyzed Formula for Cow's Milk Protein Allergy: A Randomized, Controlled Trial. International Archives of Allergy and Immunology, 177(3), 259-268. https://doi.org/10.1159/000490804
Inuo C, et al. Oral Immunotherapy Using Partially Hydrolyzed Formula for Cow's Milk Protein Allergy: a Randomized, Controlled Trial. Int Arch Allergy Immunol. 2018;177(3):259-268. PubMed PMID: 30134240.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Oral Immunotherapy Using Partially Hydrolyzed Formula for Cow's Milk Protein Allergy: A Randomized, Controlled Trial. AU - Inuo,Chisato, AU - Tanaka,Kenichi, AU - Suzuki,Satoko, AU - Nakajima,Yoichi, AU - Yamawaki,Kazuo, AU - Tsuge,Ikuya, AU - Urisu,Atsuo, AU - Kondo,Yasuto, Y1 - 2018/08/22/ PY - 2018/06/08/received PY - 2018/06/11/accepted PY - 2018/8/23/pubmed PY - 2018/12/12/medline PY - 2018/8/23/entrez KW - Cow’s milk protein allergy KW - Food allergy KW - Oral immunotherapy KW - Partially hydrolyzed formula SP - 259 EP - 268 JF - International archives of allergy and immunology JO - Int. Arch. Allergy Immunol. VL - 177 IS - 3 N2 - 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. SN - 1423-0097 UR - https://www.unboundmedicine.com/medline/citation/30134240/Oral_Immunotherapy_Using_Partially_Hydrolyzed_Formula_for_Cow's_Milk_Protein_Allergy:_A_Randomized_Controlled_Trial_ L2 - https://www.karger.com?DOI=10.1159/000490804 DB - PRIME DP - Unbound Medicine ER -