Chisato Inuo1,2,3, Kenichi Tanaka2, Yoichi Nakajima4, Kazuo Yamawaki2, Takeshi Matsubara5, Hiroshi Iwamoto5, Ikuya Tsuge4, Atsuo Urisu2, Yasuto Kondo2. 1. Department of Pediatrics, School of Medicine, Fujita Health University, Toyoake, Japan. inuo@mbh.nifty.com. 2. Department of Pediatrics, Second Teaching Hospital, Fujita Health University, Nagoya, Japan. 3. Department of Allergy, Kanagawa Children's Medical Center, Yokohama, Japan. 4. Department of Pediatrics, School of Medicine, Fujita Health University, Toyoake, Japan. 5. Clinical Nutrition Research Department, Wellness and Nutrition Science Institute, Morinaga Milk Industry Co., Ltd., Zama, Japan.
Abstract
BACKGROUND AND OBJECTIVES: The safety and tolerability of hydrolysed cow's milk protein-based formulas, particularly partially hydrolysed formulas (pHFs), in children with cow's milk allergy (CMA) remain poorly understood. We evaluated the tolerability of hydrolysed cow's milk-based formulas in children with CMA. METHODS AND STUDY DESIGN: A three-period double-blind crossover evaluation compared the allergic tolerance against three dietary cow's milk-based formulas: extensively hydrolysed cow's milk formula (eHF), pHF, and regular cow's milk formula (rCMF). The primary outcome was the rate of tolerance against a maximum of 20.0 mL of formula. RESULTS: Controlled food challenges were performed in 25 children (18 boys; 7 girls) with a median age of 4.25 years (range: 1-9 years) diagnosed with CMA. The median cow's milk-specific immunoglobulin E level was 31.9 UA/mL (range: 1.16-735 UA/mL). The tolerance rate ratios for rCMF were lower than those for pHF (2 vs 16; p<0.01) and eHF (2 vs 22; p<0.01). The allergic symptom scores induced by intake of pHF and eHF were significantly lower than those of rCMF (p=0.01 and p<0.01, respectively), and the pHF and eHF scores were not significantly different. CONCLUSIONS: Compared to rCMF, the partially and extensively hydrolysed whey and casein formulas evaluated in this study were better tolerated and therefore safer for children with CMA. Although further confirmation from additional centres is needed, our findings suggest the use of pHF in patients with mild CMA. Some children with CMA react to hydrolysed formulas; therefore, food challenge tests in these children should be undertaken with caution.
RCT Entities:
BACKGROUND AND OBJECTIVES: The safety and tolerability of hydrolysed cow's milk protein-based formulas, particularly partially hydrolysed formulas (pHFs), in children with cow's milk allergy (CMA) remain poorly understood. We evaluated the tolerability of hydrolysed cow's milk-based formulas in children with CMA. METHODS AND STUDY DESIGN: A three-period double-blind crossover evaluation compared the allergic tolerance against three dietary cow's milk-based formulas: extensively hydrolysed cow's milk formula (eHF), pHF, and regular cow's milk formula (rCMF). The primary outcome was the rate of tolerance against a maximum of 20.0 mL of formula. RESULTS: Controlled food challenges were performed in 25 children (18 boys; 7 girls) with a median age of 4.25 years (range: 1-9 years) diagnosed with CMA. The median cow's milk-specific immunoglobulin E level was 31.9 UA/mL (range: 1.16-735 UA/mL). The tolerance rate ratios for rCMF were lower than those for pHF (2 vs 16; p<0.01) and eHF (2 vs 22; p<0.01). The allergic symptom scores induced by intake of pHF and eHF were significantly lower than those of rCMF (p=0.01 and p<0.01, respectively), and the pHF and eHF scores were not significantly different. CONCLUSIONS: Compared to rCMF, the partially and extensively hydrolysed whey and casein formulas evaluated in this study were better tolerated and therefore safer for children with CMA. Although further confirmation from additional centres is needed, our findings suggest the use of pHF in patients with mild CMA. Some children with CMA react to hydrolysed formulas; therefore, food challenge tests in these children should be undertaken with caution.
Authors: Paul J Turner; Nandinee Patel; Barbara K Ballmer-Weber; Joe L Baumert; W Marty Blom; Simon Brooke-Taylor; Helen Brough; Dianne E Campbell; Hongbing Chen; R Sharon Chinthrajah; René W R Crevel; Anthony E J Dubois; Motohiro Ebisawa; Arnon Elizur; Jennifer D Gerdts; M Hazel Gowland; Geert F Houben; Jonathan O B Hourihane; André C Knulst; Sébastien La Vieille; María Cristina López; E N Clare Mills; Gustavo A Polenta; Natasha Purington; Maria Said; Hugh A Sampson; Sabine Schnadt; Eva Södergren; Stephen L Taylor; Benjamin C Remington Journal: J Allergy Clin Immunol Pract Date: 2021-08-23
Authors: Benjamin Zepeda-Ortega; Anne Goh; Paraskevi Xepapadaki; Aline Sprikkelman; Nicolaos Nicolaou; Rosa Elena Huerta Hernandez; Amir Hamzah Abdul Latiff; Miu Ting Yat; Mohamed Diab; Bakr Al Hussaini; Budi Setiabudiawan; Urszula Kudla; R J Joost van Neerven; Leilani Muhardi; John O Warner Journal: Front Immunol Date: 2021-06-10 Impact factor: 7.561