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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extensively hydrolysed casein formula + LGG | children receiving extensively hydrolysed casein formula plus Lactobacillus GG |
| |
| other formulas | children receiving formulas without supplementation of Lactobacillus GG |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extensively hydrolyzed casein formula + LGG | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appearance of functional gastrointestinal disorders | functional gastrointestinal disorders |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be enrolled from a cohort of about 300 children (aged from 4 to 6 yrs) with a history of sure diagnosis of CMA obtained in the first year of life treated with hypoallergenic formula for at least 6 months and who are already in follow-up at the Department of Pediatrics of University of Naples "Federico II".
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Naples Federico II | Naples | 80131 | Italy |
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| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| D004066 | Digestive System Diseases |