Efficacy and Saffety of Oral Immunotherapy to Pistachio

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05698030
• Other study ID #: 2022PI182
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: January 16, 2023

Study information

• Verified date: January 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 16, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Other:
• Food allergy
Oral immunotherapy to pistachio

Locations

Country	Name	City	State
France	Centre Hospitalo-Universitaire de Nancy	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of moderate to severe allergic reactions	with daily intake of 2g of pistachio	during the 6 months of maintenance
Secondary	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)
Secondary	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)
Secondary	Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of pistachio	during an oral pistachio challenge test	3 months after stopping daily consumption of 2g pistachio
Secondary	Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of cashew nut	during an oral cashew nut challenge test	3 months after stopping daily consumption of 2g pistachio
Secondary	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)