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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04651829
Other study ID # CMPA
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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