Design, quality, safety and efficacy of extensively hydrolyzed formula for management of cow's milk protein allergy: What are the challenges?

Nutten, Sophie; Schuh, Susanne; Dutter, Thibaut; Heine, Ralf G.; Kuslys, Martinas

doi:10.1016/bs.afnr.2020.04.004

Cited by 17 publications

(16 citation statements)

References 136 publications

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“…HF are manufactured through various processes, including enzymatic hydrolysis, heat-treatment, and ultrafiltration. These processes are needed to decrease, and ideally remove, the allergenicity of the resulting formula [ 14 ].…”

Section: Hydrolysed Formulas: New Regulations and Compositionmentioning

confidence: 99%

Hydrolysed Formulas in the Management of Cow’s Milk Allergy: New Insights, Pitfalls and Tips

et al. 2021

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An allergy to cow’s milk requires the avoidance of cow’s milk proteins and, in some infants, the use of a hypoallergenic formula. This review aims to summarize the current evidence concerning different types of hydrolysed formulas (HF), and recommendations for the treatment of IgE- and non-IgE-mediated cow’s milk allergy and functional gastrointestinal disorders in infancy, for which some dietary intervention and HF may be of benefit to both immune and motor mechanisms. Current guidelines recommend cow’s milk protein (i.e., whey or casein) extensively hydrolysed formula (eHF) as the first choice for cow’s milk allergy treatment, and amino acid formulas for more severe cases or those with reactions to eHF. Rice hydrolysed formulas (rHF) have also become available in recent years. Both eHF and rHF are well tolerated by the majority of children allergic to cow’s milk, with no concerns regarding body growth or adverse effects. Some hydrolysates may have a pro-active effect in modulating the immune system due to the presence of small peptides and additional components, like biotics. Despite encouraging results on tolerance acquisition, evidence is still not conclusive, thus hampering our ability to draw firm conclusions. In clinical practice, the choice of hypoallergenic formula should be based on the infant’s age, the severity, frequency and persistence of symptoms, immune phenotype, growth pattern, formula cost, and in vivo proof of tolerance and efficacy.

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Section: Hydrolysed Formulas: New Regulations and Compositionmentioning

confidence: 99%

Hydrolysed Formulas in the Management of Cow’s Milk Allergy: New Insights, Pitfalls and Tips

et al. 2021

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“…51,52 Guidelines need to be developed for minimum technical and regulatory requirements for EHF products, including validated assays for ongoing quality control. 52 Clinical trials assessing new EHF products for their hypo-allergenicity and ability to support normal growth remain the definitive proof of efficacy and safety in infants and young children with CMA. 52,53 Apart from differences in ingredients, formulas also exhibit distinct differences in smell, texture, taste and aftertaste when compared to cow's milk formulas.…”

Section: Management Options Breastfeeding and Extensively Hydrolyzed Formula In Cmamentioning

confidence: 99%

“…52 Clinical trials assessing new EHF products for their hypo-allergenicity and ability to support normal growth remain the definitive proof of efficacy and safety in infants and young children with CMA. 52,53 Apart from differences in ingredients, formulas also exhibit distinct differences in smell, texture, taste and aftertaste when compared to cow's milk formulas. 54 Overall whey EHF, in particular those containing lactose, were judged to be of better palatability than casein EHF and AAFs.…”

Section: Management Options Breastfeeding and Extensively Hydrolyzed Formula In Cmamentioning

confidence: 99%

“…Not all EHF are the same: since the type of protein (ie whey or casein) hydrolyzation technique differs between products, thus residual peptides are different, which further highlights the importance to only recommend EHF that have been tested clinically and shown to fulfill the AAP recommendations. 51 , 52 Moreover, not all commercialized EHF products have undergone formal testing in the laboratory and clinical trials. 51 , 52 Guidelines need to be developed for minimum technical and regulatory requirements for EHF products, including validated assays for ongoing quality control.…”

Section: Management Optionsmentioning

confidence: 99%

“… 51 , 52 Moreover, not all commercialized EHF products have undergone formal testing in the laboratory and clinical trials. 51 , 52 Guidelines need to be developed for minimum technical and regulatory requirements for EHF products, including validated assays for ongoing quality control. 52 Clinical trials assessing new EHF products for their hypo-allergenicity and ability to support normal growth remain the definitive proof of efficacy and safety in infants and young children with CMA.…”

Section: Management Optionsmentioning

confidence: 99%

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Current Guidelines and Future Strategies for the Management of Cow’s Milk Allergy

Vandenplas¹,

Brough²,

Fiocchi³

et al. 2021

JAA

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Exclusive breast feeding is recommended in all guidelines as the first choice feeding. Cow milk allergy (CMA) can be diagnosed by a diagnostic elimination diet for 2 to 4 weeks with a hypo-allergenic formula, followed by a challenge test with intact cow milk protein. The most often used hypo-allergenic formula for the diagnostic elimination diet and the therapeutic diet is a CM based extensive hydrolysate. CM-based partial hydrolysates cannot be recommended in the management of CMA because of insufficient efficacy and possible reactions, but about half of the infants with CMA may tolerate a partial hydrolysate. The pros and cons of other dietary options are discussed in this paper. The use of an amino acid-based formula and/or rice based hydrolysate formula during the diagnostic elimination and therapeutic diet is debated. When available, there is sufficient evidence to consider rice hydrolysates as an adequate alternative to CM-based hydrolysates, since some infants will still react to the CM hydrolysate. The pros and cons of dietary options such as soy formula, buckwheat, almond, pea or other plant based dietary products are discussed. Although the majority of the plant-based beverages are nutritionally inadequate, some are nutritionally adapted for toddlers. However, accessibility and content vary by country and, thus far there is insufficient evidence on the efficacy and tolerance of these plant-based drinks (except for soy formula and rice hydrolysates) to provide an opinion on them. Conclusion: A diagnostic elimination diet, followed by a challenge remains the diagnostic standard. The use of an awareness tool may result in a decrease of delayed diagnosis. Breastmilk remains the ideal source of nutrition and when not available a CM extensively hydrolyzed formula, rice hydrolysate or amino acid formula should be recommended. More evidence is needed regarding plant-based drinks.

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Peptide and Protein Emulsifiers

Soliman,

Khedr,

Elsawy

2023

Peptide Bionanomaterials

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Design, quality, safety and efficacy of extensively hydrolyzed formula for management of cow's milk protein allergy: What are the challenges?

Cited by 17 publications

References 136 publications

Hydrolysed Formulas in the Management of Cow’s Milk Allergy: New Insights, Pitfalls and Tips

Hydrolysed Formulas in the Management of Cow’s Milk Allergy: New Insights, Pitfalls and Tips

Current Guidelines and Future Strategies for the Management of Cow’s Milk Allergy

Peptide and Protein Emulsifiers

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