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

Atopic Dermatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651829
• Other study ID #: CMPA
• Status: Completed
• Start date: May 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2020
• Source: Hôpital Armand Trousseau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Food Allergy in Infants
• Food Hypersensitivity
• Gastroesophageal Reflux
• Hypersensitivity
• Proctocolitis
• Reflux, Gastroesophageal
• Tolerance

Intervention

Other:
• oral food challenge 1
First oral food challenge after a short period of several weeks of avoidance of CMP to confirm diagnosis of CMPA
• oral food challenge 2
Second oral food challenge to test tolerance after 4 months of age if confirmed CMPA

Locations

Country	Name	City	State
France	Pediatric nutrition and gastroenterology department, Trousseau Hospital, APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Armand Trousseau

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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