Oral immunotherapy using partially hydrolyzed formula for cow's milk protein allergy: A randomized, controlled trial

Chisato Inuo, Kenichi Tanaka, Satoko Suzuki, Yoichi Nakajima, Kazuo Yamawaki, Ikuya Tsuge, Atsuo Urisu, Yasuto Kondo

研究成果: Article

6 引用 (Scopus)

抄録

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.

元の言語English
ページ(範囲)259-268
ページ数10
ジャーナルInternational Archives of Allergy and Immunology
177
発行部数3
DOI
出版物ステータスPublished - 01-10-2018

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Milk Hypersensitivity
Milk Proteins
Immunotherapy
Randomized Controlled Trials
Caseins
Immunoglobulin E
Safety
Basophils
Epinephrine
Adrenal Cortex Hormones
Hypersensitivity
Milk
Immunoglobulin G
Antibodies

All Science Journal Classification (ASJC) codes

  • Immunology and Allergy
  • Immunology

これを引用

Inuo, Chisato ; Tanaka, Kenichi ; Suzuki, Satoko ; Nakajima, Yoichi ; Yamawaki, Kazuo ; Tsuge, Ikuya ; Urisu, Atsuo ; Kondo, Yasuto. / Oral immunotherapy using partially hydrolyzed formula for cow's milk protein allergy : A randomized, controlled trial. :: International Archives of Allergy and Immunology. 2018 ; 巻 177, 番号 3. pp. 259-268.
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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.",
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Oral immunotherapy using partially hydrolyzed formula for cow's milk protein allergy : A randomized, controlled trial. / Inuo, Chisato; Tanaka, Kenichi; Suzuki, Satoko; Nakajima, Yoichi; Yamawaki, Kazuo; Tsuge, Ikuya; Urisu, Atsuo; Kondo, Yasuto.

:: International Archives of Allergy and Immunology, 巻 177, 番号 3, 01.10.2018, p. 259-268.

研究成果: Article

TY - JOUR

T1 - Oral immunotherapy using partially hydrolyzed formula for cow's milk protein allergy

T2 - 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

PY - 2018/10/1

Y1 - 2018/10/1

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.

AB - 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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