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

NCT04651829 | Completed

• 1 other identifier: CMPA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

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

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All infants under 4 months of age consulting for delayed symptoms evoking CMPA are prospectively included. All these infants benefit from a CMP elimination diet by replacing their usual formula with an extensive CMP hydrolysate, hydrolysed rice-protein formula, or an amino acid-based formula (AAF). Only children whose symptoms disappear after this exclusion diet are selected for the study.

You may qualify if:

• infants under 4 months age with delayed symptoms evoking CMPA

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Armand Trousseau: lead

Study Sites (1)

Pediatric nutrition and gastroenterology department, Trousseau Hospital, APHP

Paris, 75012, France

Location

MeSH Terms

Conditions

Proctocolitis; Dermatitis, Atopic; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Proctitis; Colonic Diseases; Intestinal Diseases; Sigmoid Diseases; Rectal Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, MD

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: May 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2017
• Last Updated: December 3, 2020

Record last verified: 2020-11

Locations

FR (1)