Efficacy and Saffety of Oral Immunotherapy to Pistachio

NCT05698030 | Completed

• 1 other identifier: 2022PI182
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy; Food Allergy

Outcome Measures

Primary Outcomes (1)

• Absence of moderate to severe allergic reactions

  with daily intake of 2g of pistachio

  during the 6 months of maintenance

Secondary Outcomes (5)

• 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)

• 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

• 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

• 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)

Interventions

Food allergy OTHER

Oral immunotherapy to pistachio

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalo-Universitaire de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Hypersensitivity; Food Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases; Hypersensitivity, 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: MCU-PH

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: January 16, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)