Efficacy and Saffety of Oral Immunotherapy to Pistachio

January 16, 2023 updated by: Amandine DIVARET-CHAUVEAU, Central Hospital, Nancy, France

Efficacy of Oral Immunotherapy to Pistachio in Children on the Oral Tolerance to Pistachio and Cashew Nuts

The objectives of this study are (i) to evaluate the efficacy of oral immunotherapy to pistachio by evaluating the daily oral tolerance of 2g pistachio, by evaluating the long-term tolerance of 15g pistachio (sustained unresponsiveness) and by decreasing pistachio-specific IgE, (ii) evaluating the efficacy of pistachio immunotherapy on cashew tolerance, (iii) and to evaluate the safety of pistachio immunotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54511
        • Centre Hospitalo-Universitaire de Nancy

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients meeting the inclusion criteria (between 10 and 50)

Description

Inclusion Criteria:

  • Patients under 18 years of age with a proven allergy to pistachio and followed in the pediatric allergology unit of the Nancy University Hospital.
  • Patients who have received oral immunotherapy to pistachio for at least 18 months at 31/12/2022

Exclusion Criteria:

  • Patients who have received oral immunotherapy to pistachio for less than 18 months.
  • Patients lost to follow-up for more than 2 years or 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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of moderate to severe allergic reactions
Time Frame: during the 6 months of maintenance
with daily intake of 2g of pistachio
during the 6 months of maintenance

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and severity of allergic reactions
Time Frame: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
Decrease in specific IgE and increase of IGg4 to pistachio
Time Frame: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of pistachio
Time Frame: 3 months after stopping daily consumption of 2g pistachio
during an oral pistachio challenge test
3 months after stopping daily consumption of 2g pistachio
Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of cashew nut
Time Frame: 3 months after stopping daily consumption of 2g pistachio
during an oral cashew nut challenge test
3 months after stopping daily consumption of 2g pistachio
Reactogenic or tolerogenic threshold of cashew nuts
Time Frame: during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)
during the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Amandine DIVARET-CHAUVEAU, Centre Hospitalo-Universitaire de Nancy

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 (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 16, 2023

Study Registration Dates

First Submitted

January 16, 2023

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022PI182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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