Published online Aug 26, 2019. doi: 10.12998/wjcc.v7.i16.2256
Peer-review started: March 6, 2019
First decision: May 10, 2019
Revised: July 18, 2019
Accepted: July 27, 2019
Article in press: July 27, 2019
Published online: August 26, 2019
Cow’ milk protein allergy is the most frequent allergy in infant and young children. Its dietary management consists of the elimination of any cow’s milk protein from the diet. In infant and young children, infant formula has to be replaced by an adapted formula which protein do not provoke reaction. This has to be demonstrated by a double-blind placebo controlled food challenge according to the American Academy of Pediatrics.
A new thickened extensively hydrolyzed casein-based formula (TeHCF) has been developed to manage concomitant presence of cow’s milk allergy (CMA) and regurgitation. However, as a first step, its hypoallergenicity had to be assessed.
The objective of this study was to assess the hypoallergenicity of a new TeHCF in children with CMA.
In children diagnosed with CMA through a double-blind placebo-controlled food challenge (DBPCFC), the hypoallergenicity of the new thickened formula was assessed through a DBPCFC: children were randomly administered increased doses of a placebo formula or the TeHCF under double-blind conditions and medical surveillance on two separate days. In children highly suspected of CMA, the hypoallergenicity of the formula and the CMA diagnosis were assessed simultaneously during a 3-days food challenge. 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
30 children have been included in the study between April 2016 to July 2017. CMA diagnosis was confirmed by a DBPCFC in 29 (mean age: 8.03 ± 7.43 mo) patients. 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 Cow’s Milk-related Symptoms Score remained at a very low level, never exceeding its baseline value (1.4 ± 2.0), growth parameters were within World Health Organization 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. The efficacy on regurgitations in a specific population of infants having CMA and regurgitation should be assessed.
This study demonstrates that the new thickened extensively hydrolysed formula is hypoallergenic. The design of our study, allowing to combine DBPCFC for CMA diagnosis and evaluation of the hypoallergenicity reduced burden for the family while allowing a sure diagnosis of CMA. Moreover, the tolerance was not assessed only during 7 d feeding period as per the American Academy of Pediatrics but through a 3-mo feeding period, in conditions similar to daily practices.
Further studies should investigate the effect of this new thickened extensively hydrolysed formula in a patient population whose allergic symptoms are still present.