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Cow's milk protein allergy (CMPA) is often evoked in infants, in particular in front of delayed symptoms such as rectal bleeding, atopic dermatitis, excessive crying, reflux, failure to thrive... But in case of non IgE-mediated CMPA, the only way to diagnose this allergy is to proceed to an elimination-reintroduction test over a period of 2 to 4 weeks, to improve symptoms first, and then provoke them. Even if the diagnosis is confirmed, we speculate that non IgE-mediated CMPA has a faster resolution than other CMPA.
The first aim of this study is to estimate the prevalence of non IgE-mediated CMPA in a cohort of infants with delayed symptoms which could be relied to a CMPA. The second goal is evaluate the age of tolerance in non IgE-mediated CMPA with oral food challenge for milk ever 2 months after 4 months of age.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral food challenge 1 | Other | First oral food challenge after a short period of several weeks of avoidance of CMP to confirm diagnosis of CMPA | ||
| oral food challenge 2 | Other | Second oral food challenge to test tolerance after 4 months of age if confirmed CMPA |
| Measure | Description | Time Frame |
|---|---|---|
| prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA | We proceed to an elimination-reintroduction test of the culprit food (CMP) in patients with delayed symptoms of non IgE-mediated CMPA (rectal bleeding, atopic dermatitis, reflux, excessive crying, failure to thrive...) after a period of two to eight weeks of exclusion of CMP. If symptoms disappear after CMP elimination, and reappear after CMP reintroduction, the diagnosis of CMPA is confirmed. | 2 to 8 weeks after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| age of tolerance of confirmed non IgE-mediated CMPA | We proceed to an oral food challenge (OFC) for CMP every 2 months, after the age of 4 months, and after at least 2 months of elimination diet. If symptoms occur after OFC, the patient is still allergic. If no symptom occur after OFC, the patient is considered as tolerant for CMP, and that determine age of tolerance. | after 4 months of age, and at least after 2 months of elimination diet, and then ever 2 months until tolerance |
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Inclusion Criteria:
Exclusion Criteria:
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All infants under 4 months of age consulting for delayed symptoms evoking CMPA are prospectively included. All these infants benefit from a CMP elimination diet by replacing their usual formula with an extensive CMP hydrolysate, hydrolysed rice-protein formula, or an amino acid-based formula (AAF). Only children whose symptoms disappear after this exclusion diet are selected for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric nutrition and gastroenterology department, Trousseau Hospital, APHP | Paris | 75012 | France |
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| ID | Term |
|---|---|
| D011350 | Proctocolitis |
| D003876 | Dermatitis, Atopic |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D011349 |
| Proctitis |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012810 | Sigmoid Diseases |
| D012002 | Rectal Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |