Efficacy and Safety of Oral Cashew Nut Immunotherapy in Children (CAJESITO) (CAJESITO)

April 21, 2023 updated by: Amandine DIVARET-CHAUVEAU, Central Hospital, Nancy, France
The objectives of the CAJESITO study are (i) to assess the tolerance of oral cashew nut immunotherapy, by describing the frequency and severity of allergic reactions during oral cashew nut immunotherapy and (ii )to assess the risk factors for severe allergic reactions during oral cashew nut immunotherapy (predictive factors, associated factors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients from 0 to 18 years old followed in allergology at the University Hospital of Nancy benefiting from oral immunotherapy with cashew nuts for at least 18 months as of 02/28/2023

Description

Inclusion Criteria:

  • Patients under the age of 18 with a proven allergy to cashew nuts and followed in the pediatric allergology unit of the University Hospital of Nancy.
  • Patients who have received oral cashew nut immunotherapy for at least 18 months as of 02/28/2023

Exclusion Criteria:

  • Patients who have received oral cashew nut immunotherapy for less than 18 months.
  • Patients lost to follow-up for more than 3 years, i.e. last consultation dating from 2020 or earlier

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cashew Nut allergic
Other: No intervention
No intervention, it's an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of allergic reaction
Time Frame: during 6 months
during 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive factor of good tolerance
Time Frame: during 6 months
age at onset
during 6 months
antibody variation
Time Frame: during 6 months
Modification of level of specific IgE and IGg4 with cashew nuts
during 6 months
sustained unresponsiveness
Time Frame: 9 months
Tolerance of 1, 2, 4, 8g in isolated doses and 15g in total cumulative dose of cashew nuts during an oral challenge test with cashew nuts 3 months after stopping the daily consumption of 2g of cashew nuts
9 months
oral tolerance of pistachio
Time Frame: 6 months
Tolerance of 1, 2, 4, 8g in isolated doses and 15g in total cumulative dose of pistachio during an oral provocation test with pistachio 3 months after stopping the daily consumption of 2g of cashew nuts
6 months
Predictive factor of good tolerance
Time Frame: 6 months
antecedent of severe allergic reaction
6 months
Predictive factor of good tolerance
Time Frame: 6 months
initial reactogenic threshold
6 months
Predictive factor of good tolerance
Time Frame: 6 months
presence atopy (asthma, food allergy or atopic dermatitis)
6 months
Predictive factor of good tolerance
Time Frame: 6 months
initial specific IgE and Ana o3 levels
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 10, 2023

Primary Completion (Anticipated)

May 10, 2023

Study Completion (Anticipated)

May 10, 2023

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FORM-03935

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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