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OpenTrials
Completed

NCT Number: NCT05698030

Efficacy and Saffety of Oral Immunotherapy to Pistachio

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.

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Key information

Conditions

Allergy Food Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalo-Universitaire de Nancy

Vandœuvre-lès-Nancy, 54511, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Food allergy

Other

Oral immunotherapy to pistachio

Primary outcomes

  1. Absence of moderate to severe allergic reactions

    Time frame: during the 6 months of maintenance

    with daily intake of 2g of pistachio

Secondary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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)

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 26, 2023
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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