Cow's milk allergy Not Applicable
Conditions
Interventions
Following the diagnosis of cow's milk allergy, the children start a commercially available extensively hydrolyzed casein formula (EHCF, Nutramigen, Mead Johnson, Rome, Italy) and treatment with the pr
1 bnl CFU/die of Bifidobacterium Infantis M-63
1 1 bnl CFU/die of Bifidobacterium breve M-16V).
Blood samples are collected soon before the probiotic treatment (baseline, T0) and at the end of probiotic supplementation (T1). Furth
Sponsors
Azienda Ospedaliera Universitaria Università degli Studi della Campania Luigi Vanvitelli
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Paediatric patients with an allergy to cow’s milk proteins (CMA)
Exclusion criteria
Exclusion criteria: 1. Consumption of prebiotic or probiotic products, and/or antibiotics in the previous 4 weeks 2 . A history of cow’s milk-induced anaphylaxis 3. Eosinophilic disorders of the gastrointestinal tract 4. Food protein-induced enterocolitic syndrome 5. Concomitant chronic systemic diseases 6. Other gastrointestinal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of various lymphocyte subsets in peripheral blood (e.g. T cells [CD3+, either the helper CD4+ and the cytotoxic CD8+ cells], and B cells [CD19+]) evaluated by flow cytometry at baseline, after 45 days of probiotic treatment (T1) and 45 days from the suspension of the treatment (T2) | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of degranulation activity of circulating basophils evaluated in fresh blood samples using the basophilic activation test (BAT) after in vitro exposure to cow’s milk, casein, lactalbumin and lactoglobulin reported at baseline, at T1 and T2 | — |
Countries
Italy
Outcome results
None listed