Suspicion of Non IgE-mediated Cow's Milk Protein Allergy: Prevalence and Evolution

Completed

• Conditions: Atopic Dermatitis; Reflux, Gastroesophageal; Food Allergy in Infants; Proctocolitis; Tolerance

• Registration Number: NCT04651829
• Lead Sponsor: Hôpital Armand Trousseau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2014-05
• Study Completion: 2017-12
• Status Verified: 2020-11
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Last Update Submitted: 2020-11-26
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Pediatric nutrition and gastroenterology department, Trousseau Hospital, APHP; 🇫🇷 Paris, France