The step‐down approach in children with cow's milk allergy: Results of a randomized controlled trial

Abstract

BackgroundThe Step‐Down Approach for Cow's Milk Allergy (SDACMA) trial evaluated the tolerability and the rate of immune tolerance acquisition in CMA children starting dietary treatment with amino acid‐based formula (AAF) and then switching to EHCF containing the probiotic Lacticaseibacillus rhamnosus GG (EHCF + LGG).MethodsRandomized controlled trial involving IgE‐mediated CMA children receiving AAF from at least 4 weeks. EHCF + LGG tolerance was evaluated by the results of double‐blind placebo‐controlled food challenge (DBPCFC). Subjects tolerating EHCF + LGG were randomly allocated to remain on AAF, or to switch to EHCF + LGG. Immune tolerance acquisition to cow's milk proteins was evaluated with DBPCFC after 12 months of treatment. Allergy screening tests and body growth were also monitored.ResultsSixty IgE‐mediated CMA children were enrolled. The proportion of children treated with AAF who resulted tolerant to the first exposure of EHCF + LGG was 0.98 (exact 95% CI 0.91–0.99). The rate of the immune tolerance acquisition to cow milk proteins after 12 months treatment was higher in the EHCF + LGG (0.48, 95% exact CI 0.29–0.67, n/N = 14/29) than in the AAF group (0.03, 95% exact CI 0.001–0.17, n/N = 1/30). There was an absolute benefit increase (ABI) of tolerance rate equal to 0.45 (95% CI 0.23–0.63, Newcombe method 10) for EHCF + LGG versus AAF, corresponding to a NNT of 2 (2–4, Bender's method). A normal body growth pattern was observed in the two study groups.ConclusionIn IgE‐mediated CMA children the step‐down from AAF to EHCF + LGG is well tolerated and could facilitate the immune tolerance acquisition.

Oral Immunotherapy With Extensively Hydrolyzed Milk for a 12-Year-Old Child With Persistent, Severe Cow’s Milk Allergy

“…In a recent study, 60 infants younger than six months with CMA were randomized to receive a non-allergenic amino acid-based or less allergenic extensively hydrolyzed formula. Remission rates were compared at 12 months [ 7 ]. Three percent and 48% of infants in the amino acid-based and extensively hydrolyzed formula groups, respectively, achieved remission, with no severe allergic symptoms associated with the extensively hydrolyzed formula.…”

Molecular Mechanism and Clinical Effects of Probiotics in the Management of Cow’s Milk Protein Allergy

“…After 12 months, the rate of CT was higher in the EHCF + LGG group (0.48, 95% exact CI 0.29–0.67, n /N = 14/29) than in the AAF group (0.03, 95% exact CI 0.001–0.17, n /N = 1/30). They demonstrated that in IgE-mediated CMPA children, the step-down from AAF to EHCF + LGG was well tolerated and could facilitate the immune tolerance acquisition [ 127 ].…”

Research progress on the mechanism of probiotics regulating cow milk allergy in early childhood and its application in hypoallergenic infant formula

“…However, the health effect of probiotics has high strain tolerance, and infants with different constitutions, different genetic backgrounds and different intestinal flora should be different, and the research on probiotics can be located on the individual strains. At present, researchers have evaluated the safety and the efficacy of EHCF with LGG by randomized, double-blind trial, and the results showed that EHCF + LGG could be tolerated by the vast majority of IgE-mediated CMA children, and that the step-down approach from AFF to EHCF + LGG could promote a faster acquisition of immune tolerance ( 119 ). Although the use of probiotics is beneficial to promote immune regulation and alleviate clinical symptoms, more methodologically based and homogenized research is needed to more specifically study each type, dose, and time of probiotic supplementation for the establishment of definitive care protocols.…”