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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Food Allergy in Infants Proctocolitis Atopic Dermatitis Reflux, Gastroesophageal Tolerance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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oral food challenge 1

First oral food challenge after a short period of several weeks of avoidance of CMP to confirm diagnosis of CMPA

Intervention Type OTHER

oral food challenge 2

Second oral food challenge to test tolerance after 4 months of age if confirmed CMPA

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Anaïs Lemoine

Dr, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric nutrition and gastroenterology department, Trousseau Hospital, APHP

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CMPA

Identifier Type: -

Identifier Source: org_study_id