Efficacy and Saffety of Oral Immunotherapy to Pistachio

Completed

• Conditions: Allergy; Food Allergy

• Registration Number: NCT05698030
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2023-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-16
• Study First Submitted: 2023-01-16
• Study First Submitted QC: 2023-01-16
• Last Update Submitted: 2023-01-16
• Study First Posted: 2023-01-26
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of moderate to severe allergic reactions	during the 6 months of maintenance	with daily intake of 2g of pistachio

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalo-Universitaire de Nancy; 🇫🇷 Vandœuvre-lès-Nancy, France