NCT06589232

Brief Summary

The main objective of this study is to describe the distribution of reactogenic thresholds for pistachio. The secondary objectives are to 1) describe the clinical severity of allergic reactions to pistachio in an oral challenge test, 2) compare the reactogenic thresholds of pistachio and cashew nut on matched data and 3) evaluate predictive factors of a low reactogenic threshold

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

April 1, 2024

Enrollment Period

3.2 years

First QC Date

April 10, 2024

Last Update Submit

September 5, 2024

Conditions

AllergyFood Allergy

Outcome Measures

Primary Outcomes (1)

  • Threshold dose to pistachio

    in mg of protein

    in the 4 hours of monitoring

Secondary Outcomes (2)

  • Threshold dose to cashew

    in the 4 hours of monitoring

  • Severity of the reaction during a positive pistachio oral provocation test

    in the 4 hours of monitoring

Study Arms (1)

Food allergy

Threshold dose to pistachio

Other: Food allergy

Interventions

Food allergyOTHER

Threshold dose to pistachio

Food allergy

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients under 18 years of age who had a positive pistachio challenge test between January 2021 and December 2023, in the pediatric allergology unit of the Nancy CHRU

You may qualify if:

  • Patients under 18 years of age who had a positive pistachio challenge test between January 2021 and December 2023, in the pediatric allergology unit of the Nancy CHRU.

You may not qualify if:

  • Patients who had a questionable oral pistachio provocation test.
  • Patients who had a negative pistachio oral provocation test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalo-Universitaire de Nancy

Vandœuvre-lès-Nancy, France, 54511, France

Location

MeSH Terms

Conditions

HypersensitivityFood Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System DiseasesHypersensitivity, Immediate

Study Officials

  • Amandine DIVARET-CHAUVEAU

    Centre hospitalo-universitaire de Nancy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 10, 2024

First Posted

September 19, 2024

Study Start

January 1, 2021

Primary Completion

April 1, 2024

Study Completion

April 9, 2024

Last Updated

September 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)