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

J Pediatr. 2019 Oct;213:137-142.e2. doi: 10.1016/j.jpeds.2019.06.004. Epub 2019 Jul 18.


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.

Keywords: food allergy; functional abdominal pain; functional constipation; functional dyspepsia; gut microbiota; irritable bowel syndrome; probiotics.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Caseins / chemistry*
  • Cattle
  • Child
  • Child, Preschool
  • Diet
  • Female
  • Food, Formulated*
  • Gastrointestinal Diseases / prevention & control*
  • Humans
  • Hydrolysis
  • Immune Tolerance
  • Lactobacillus rhamnosus*
  • Male
  • Milk
  • Milk Hypersensitivity / diet therapy*
  • Prevalence
  • Probiotics / administration & dosage*
  • Prospective Studies
  • Risk
  • Treatment Outcome


  • Caseins