Atopic Dermatitis, Food Allergy in Infants, Proctocolitis, Reflux, Gastroesophageal, Tolerance
Conditions
Brief summary
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.
Interventions
OTHERoral food challenge 1
First oral food challenge after a short period of several weeks of avoidance of CMP to confirm diagnosis of CMPA
OTHERoral food challenge 2
Second oral food challenge to test tolerance after 4 months of age if confirmed CMPA
Sponsors
Hôpital Armand Trousseau
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Months
Healthy volunteers
No
Inclusion criteria
* infants under 4 months age with delayed symptoms evoking CMPA
Exclusion criteria
* exclusively breastfed infants * no improvement of symptoms despite amino acid formula * patients with symptoms of food protein induced enterocolitis * patients who do not have diagnostic oral food challenge within 3 months after the start of elimination diet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA | 2 to 8 weeks after inclusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| age of tolerance of confirmed non IgE-mediated CMPA | after 4 months of age, and at least after 2 months of elimination diet, and then ever 2 months until tolerance | 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. |
Countries
France
Outcome results
None listed