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Efficacy and Saffety of Oral Immunotherapy to Pistachio

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05698030
Enrollment
50
Registered
2023-01-26
Start date
2020-01-01
Completion date
2023-01-16
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy, Food Allergy

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.

Interventions

OTHERFood allergy

Oral immunotherapy to pistachio

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Absence of moderate to severe allergic reactionsduring the 6 months of maintenancewith daily intake of 2g of pistachio

Secondary

MeasureTime frameDescription
Frequency and severity of allergic reactionsduring 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 pistachioduring 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 pistachio3 months after stopping daily consumption of 2g pistachioduring an oral pistachio challenge test
Tolerance of 1, 2, 4, 8g in isolated doses and 15 g in total cumulative dose of cashew nut3 months after stopping daily consumption of 2g pistachioduring an oral cashew nut challenge test
Reactogenic or tolerogenic threshold of cashew nutsduring the dose escalation phase and during the maintenance phase (first 6 months, 1st year, 2nd year, 3rd year)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026