Observatory on Cow's Milk Protein Allergy

NCT06085118 | Recruiting

• 1 other identifier: 2023-A01285-40
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patient

Infants up to and including 8 months of age (up to 8 months and 29 days), treated for a suspected or confirmed cow protein allergy.

Other: Pepticate® Syneo®

Interventions

Pepticate® Syneo® OTHER

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

Patient

Eligibility Criteria

• Age: Up to 8 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The target population of our project will be infants up to and including 8 months of age (up to 8 months and 29 days), treated for a suspected or confirmed, newly diagnosed cow protein allergy requiring, according to the investigator's judgement, an initial prescription of the Pepticate® Syneo® advanced cow protein hydrolysate infant formula.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutricia Nutrition Clinique: lead

Study Sites (2)

Cabinet du Dr Phu My TRAN

Nice, 06300, France

RECRUITING

Hôpital Trousseau - APHP

Paris, 75012, France

NOT YET RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Line JOUANNIC

CONTACT

603883762; line.samier@danone.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: June 17, 2024
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): November 1, 2031
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

FR (2)