Lupine Allergy in Children

Lupine Allergy in Children: Relevance of Sensitization and Severity of Reaction

All children sensitized to lupine who have performed an oral food challenge (OFC) to lupine between January 2017 and May 2024 in the Pediatric Allergy Unit of the University Hospital of Nancy were included. Retrospective data regarding food and respiratory allergies were collected as well as information regarding lupine skin prick test (SPT), specific IgE (sIgE) and OFC. Severity of allergic reaction was evaluated by CoFAR grade and reactogenic cumulative threshold dose.

Aims of this study were (i) to assess relevance of sensitization to lupine in children and (ii) to describe severity of reactions in case of allergy.

Study Overview

• Status: Completed
• Conditions: Food Allergy in Children
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 39

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

children under 18 years as the study was done in the Pediatric Allergy department

Description

Inclusion Criteria:

• cutaneous or biological sensitization to lupine

Exclusion Criteria:

• oral food challenge done with something other than lupine flour

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic value of prick test and specific IgE	prick test to lupine flour in mm done during interview and collected retrospectively Specific IgE in kU/L to lupine seed done during same interview and collected retrospectively prick test and sIgE done as in usual clinical practice main outcome of the study are statistical tests (ROC curve) done to analyse diagnostic values of prick test and sIgE in this population	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severity of allergic reaction in oral food challenge	grading the severity of allergic reaction in oral food challenge with lupine flour using CoFAR scale retrospectively	baseline

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: March 30, 2025
• First Submitted That Met QC Criteria: April 5, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 2025LAIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No