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
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.
To assess the hypoallergenicity of a new thickened extensively hydrolyzed casein-based formula (TeHCF) in children with cow’s milk allergy (CMA).
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 (CoMiSSTM) was assessed and anthropometric parameters were compared to World Health Organization (WHO) reference data.
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 CoMiSSTM 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.
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 population.
Core tip: The hypoallergenicity of the new tested formula as the primary criterion was rigorously confirmed through a properly designed double-blind placebo-controlled food challenge (DBPCFC) in children with a diagnosis of cow’s milk allergy (CMA) that was confirmed by a DBPCFC, the gold standard diagnostic procedure for food allergies. The subsequent 3-mo open exclusive feeding with the tested formula showed that the formula was still well tolerated by the 29 children with CMA included, their growth was adequate, and parents and the investigator were very satisfied with the effect of the formula.