Cow's Milk Allergy and Functional Gastrointestinal Disorders

Study Overview
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Brief Summary
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Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an estimated incidence ranging between 2% and 3% in infants and marginally lower in older children. It has been demonstrated that it could be a risk factor for the development of the functional gastrointestinal disorders in children. Intestinal microflora has been indicated as potential target for the management of CMA and FGDIs through the use of probiotics. Lactobacillus rhamnosus GG (LGG) is the most studied probiotic. Recently, it has been demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following the addition of LGG, satisfying both the American Academy of Pediatrics guidelines. Lactobacillus GG exerts several benefits when added to an extensively hydrolyzed casein formula (Nutramigen LGG), including decreased severity of atopic dermatitis, improved recovery of intestinal symptoms in infants with CMA-induced allergic colitis, and faster induction of tolerance in infants with CMA. The mechanisms of these effects are multiple and exerted at different levels: epithelium, immune system and enteric nervous system. Studies and meta-analyses showed that LGG increases treatment success in children with functional gastrointestinal disorders.

Official Title
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Effect of Lactobacillus GG on the Appearance of Functional Gastrointestinal Disorders in Children With Cow's Milk Allergy

Conditions
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Cow's Milk Allergy, Functional Gastrointestinal Disorders

Intervention / Treatment
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* Dietary Supplement: Extensively hydrolyzed casein formula + LGG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (aged from 4 to 6 yrs) with a history of sure diagnosis of cow's milk allergy obtained in the first year of life treated with hypoallergenic formula Exclusion Criteria: Age higher than 12 months, concomitant chronic systemic diseases, congenital cardiac defects, active tuberculosis, autoimmune diseases, immunodeficiency, chronic inflammatory bowel diseases, celiac disease, cystic fibrosis, metabolic diseases, malignancy, chronic pulmonary diseases, malformations of the gastrointestinal tract, suspected eosinophilic esophagitis or eosinophilic enterocolitis, suspected food-protein-induced enterocolitis syndrome, suspected cow's milk proteins-induced anaphylaxis.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| extensively hydrolysed casein formula + LGG<br>children receiving extensively hydrolysed casein formula plus Lactobacillus GG | Dietary Supplement: Extensively hydrolyzed casein formula + LGG<br> <br> |
| other formulas<br>children receiving formulas without supplementation of Lactobacillus GG | Dietary Supplement: Extensively hydrolyzed casein formula + LGG<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of functional gastrointestinal disorders |  | functional gastrointestinal disorders |