Dietary Treatment with Extensively Hydrolyzed Casein Formula Containing the Probiotic Lactobacillus rhamnosus GG Prevents the Occurrence of Functional Gastrointestinal Disorders in Children with Cow's Milk Allergy.

2019-10
The Journal of pediatrics 213
- Rita Nocerino
- Margherita Di Costanzo
- Giorgio Bedogni
- Linda Cosenza
- Ylenia Maddalena
- Carmen Di Scala
- Giusy Della Gatta
- Laura Carucci
- Luana Voto
- Serena Coppola
- Anna Maria Iannicelli
- Roberto Berni Canani

PubMed: 31327562
DOI: 10.1016/j.jpeds.2019.06.004

Study Design

Type: Clinical Trial
Sample size: n = 330
Population: children with a positive history for CMA in the first year of life who were treated with EHCF alone or in combination with LGG and had evidence of immune tolerance acquisition to cow's milk for at least 12 months
Methods: This cohort study included children treated with EHCF alone or in combination with LGG; FGID diagnosed according to Rome III criteria by investigators unaware of previous treatment; a cohort of consecutive healthy children was also evaluated as a control population
Funding: Unclear

Large Human Trial

Objective

To investigate whether the addition of the probiotic Lactobacillus rhamnosus GG (LGG) to the extensively hydrolyzed casein formula (EHCF) for cow's milk allergy (CMA) treatment could reduce the occurrence of functional gastrointestinal disorders (FGIDs).

Study design

This cohort study included children with a positive history for CMA in the first year of life who were treated with EHCF alone or in combination with LGG and had evidence of immune tolerance acquisition to cow's milk for at least 12 months. FGID was diagnosed according to the Rome III diagnostic criteria by investigators unaware of previous treatment. A cohort of consecutive healthy children was also evaluated as a control population.

Results

A total of 330 subjects were included, 110 per cohort (EHCF, EHCF+LGG, and healthy controls). The rate of subjects with ≥1 FGID was significantly lower in the EHCF+LGG cohort compared with the EHCF cohort (40% vs 16.4%; P < .05). In the EHCF+LGG cohort, a lower incidence was observed for all components of the main study outcome. The prevalence of FGIDs in the healthy cohort was lower than that in the EHCF cohort and similar to that in the EHCF+LGG cohort. The incidence rate ratio of FGIDs for the EHCF+LGG cohort vs the EHCF cohort (0.40; 95% CI, 0.25-0.65; P < .001) was unmodified after correction for age at CMA diagnosis, breastfeeding, weaning time, and presence of a first-degree relative with an FGID.

Conclusions

These results confirm the increased risk for developing FGIDs in children with CMA and suggest that EHCF+LGG could reduce this risk.