Observatory on Cow's Milk Protein Allergy

Food Allergy Clinical Trial

— OLAF  

Official title:

Prospective National Observatory for Cow's Milk Protein Allergy.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06085118
• Other study ID #: 2023-A01285-40
• Status: Not yet recruiting
• Start date: November 2023
• Est. completion date: November 2031

Study information

• Verified date: October 2023
• Source: Nutricia Nutrition Clinique
• Contact: Line JOUANNIC
• Phone: 603883762
• Email: line.samier[@]danone.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the Pepticate® Syneo® replacement formula as soon as they were diagnosed. The Pepticate® Syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. This is a product already available on the market.

Description:

This is a prospective, observational, descriptive, longitudinal, multicentric study aimed at describing a cohort of infants with a recently suspected or confirmed allergy to cow's milk protein, who were treated in outpatient and inpatient settings. The recruitment of patients eligible for this observatory will be done via community medicine (private practices of pediatricians and general practitioners) as well as in hospitals throughout France.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: November 2031
• Est. primary completion date: November 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Months

Eligibility

Inclusion Criteria:

• Infants up to and including 8 months (up to 8 months and 29 days).
• Initial diagnosis of allergy to cow proteins, suspected (clinical presumption) or confirmed.
• Prescription of the substitution formula Pepticate® Syneo, according to the doctor's judgement, whether the child is under mixed or weaned breastfeeding.
• Authorisation from a legal representative for the child to take part in the observatory and to collect personal information about the child and the family.
• Membership of the social security system.

Exclusion Criteria:

• Infants who have already received partial or total replacement infant formula (regardless of the type of infant formula).
• Contraindication to the use of symbiotics (short small intestine, parenteral nutrition, post-pyloric feeding, central venous catheter) due to the use of Pepticate® Syneo®.
• Diagnosis of severe cow protein allergy requiring an infant amino acid formula from the outset.
• The child's legal guardian is protected (under legal protection, or deprived of liberty by judicial or administrative decision).
• The legal representative is unable to understand the study protocol.

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Other:
• Pepticate® Syneo®
Introduction of the nutritional treatment Pepticate® Syneo® (high protein hydrolysate), as a foodstuff for special medical purposes (product already available on the market).

Locations

Country	Name	City	State
France	Hôpital Trousseau - APHP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia Nutrition Clinique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and proportion of symptoms	Numbers and proportion of symptoms (cutaneous, gastrointestinal, respiratory...), and their evolution according to the different forms of cow protein allergy: immediate Immunoglobulin E mediated, delayed non-Immunoglobulin E mediated or mixed and acute food protein-induced enterocolitis syndrome.	5 years