Hypoallergenicity of a thickened hydrolyzed formula in children with cow’s milk allergy

Abstract

BACKGROUND Allergy to cow’s milk is the most frequent allergy occurring in infants and young children. The dietary management of these patients consists of the elimination of any cow’s milk proteins from the diet, and for formula-fed infants, the substitution of the usual infant formula with an adapted formula that is generally based on extensively hydrolyzed cow’s milk proteins. The American Academy of Pediatrics has established specific criteria to confirm the hypoallergenicity of a formula intended for these children. AIM To assess the hypoallergenicity of a new thickened extensively hydrolyzed casein-based formula (TeHCF) in children with cow’s milk allergy (CMA). METHODS Children diagnosed with CMA through a double-blind placebo-controlled food challenge (DBPCFC) were randomly administered increased doses of a placebo formula or the TeHCF [Allernova, new thickener including fibres (Novalac)] under double-blind conditions and medical surveillance on two separate days. Otherwise, both of these formulas and a cow’s milk-based formula were randomly introduced to children who were highly suspected of having CMA on three separate days. Immediate and late reactions occurring after the introduction of any of these formulas were thoroughly recorded by the physician at the hospital and reported by parents to the physician after hospital discharge, respectively. If the children tolerated the TeHCF during the DBPCFC, they were exclusively fed this formula during a 3-mo period where potential allergic symptoms, anthropometric parameters, as secondary outcomes, and adverse events were registered. The Cow’s Milk-related Symptoms Score (CoMiSS TM ) was assessed and anthropometric parameters were compared to World Health Organization (WHO) reference data. RESULTS Of the 30 children included in the study, the CMA diagnosis of 29 (mean age: 8.03 ± 7.43 mo) patients was confirmed by a DBPCFC. The children all tolerated the TeHCF during both the challenge and the subsequent 3-mo feeding period, which they all completed. During the latter period, the CoMiSS TM remained at a very low level, never exceeding its baseline value (1.4 ± 2.0), growth parameters were within WHO reference standards and no adverse event related to the TeHCF was reported. Over the first week of this period, the proportion of patients with digestive discomfort significantly decreased from 20.7% (6/29) to 3.4% (1/29), P = 0.025. The proportion of satisfaction with the overall effect of the formula reported by the parents and investigator was high, as was the formula acceptability by the child. CONCLUSION The new TeHCF meets the hypoallergenicity criteria according to the American Academy of Pediatrics standards, confirming that the tested TeHCF is adapted to the dietary management of children with CMA. Moreover, growth was adequate in the included p...

Symptom scores in the diagnosis of pediatric cow’s milk protein allergy: A systematic review

“…Five studies reported use of CoMiSS™ as an outcome measure (see Table 4). 27–31 In all studies, after symptomatic infants were administered cow's milk‐free formula, there was a significant change in CoMiSS™ score, but no minimally important difference has been established.…”

The Cow’s Milk-Related Symptom Score (CoMiSS™): A Useful Awareness Tool

“…In the studies by Dupont et al, Fierro et al, and Rossetti et al, the authors used CoMiSS as a tracking tool to demonstrate the stable low CoMiSS after introducing the new test formula in infants already diagnosed with CMA responding to an elimination diet [ 20 , 24 , 31 ].…”

“…A systematic review by Thompson et al [ 40 ], including 15 diagnostic-accuracy studies [ 14 , 16 , 17 , 18 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 28 , 29 , 30 , 42 ], considered that there is no well-defined diagnostic role for symptom-based scores, including CoMiSS, and that current estimates of their accuracy should be interpreted with caution.…”

Diagnosis and management of food allergy‐associated gastroesophageal reflux disease in young children—EAACI position paper

“…There are now thickened casein-based EHF and AAF with proven hypoallergenicity suitable for these patients available in some countries. [89][90][91][92] The studies by Dupont et al 91,93 and Vandenplas et al 90 To determine cow's milk tolerance in clinical practice, tolerance development may be indicated by a child tolerating milk in small quantities, baked or probably also in some fermented forms Heine 71 Milk avoided and substituted with hypoallergenic formula or maternal exclusion and sleeping time. In children that had challenge positive CMA, both thickened and un-thickened extensive hydrolysates were equally tolerated and for those that were challenge positive, a thickened hydrolysate had a significantly better impact than a non-thickened hydrolysate.…”

“… 88 However, none of the current guidelines on CMA, cover hypoallergenic formulas that have specifically been designed for GORD. There are now thickened casein‐based EHF and AAF with proven hypoallergenicity suitable for these patients available in some countries 89‐92 . The studies by Dupont et al 91,93 and Vandenplas et al 90 also assessed regurgitation episodes, crying and sleeping time.…”