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

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.

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Key information

Conditions

Food Allergy in Infants Atopic Dermatitis Colitis Colonic Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deglutition Disorders Dermatitis Dermatitis, Atopic Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroenteritis Gastroesophageal Reflux Gastrointestinal Diseases Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Intestinal Diseases Proctitis Proctocolitis Rectal Diseases Reflux, Gastroesophageal Sigmoid Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases Tolerance

Age range

Up to 4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric nutrition and gastroenterology department, Trousseau Hospital, APHP

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral food challenge 1

Other

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

oral food challenge 2

Other

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

Primary outcomes

prevalence of CMPA in patients with suspicion of non IgE-mediated CMPA

Time frame: 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 outcomes

age of tolerance of confirmed non IgE-mediated CMPA

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hôpital Armand Trousseau

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2017
First posted: Dec 3, 2020
Registry last updated: Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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