Efficacy and Saffety of Oral Immunotherapy to Pistachio

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT05698030
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Actual Duration (Months): 36.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergy; Food Allergy	Other: Food allergy

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Efficacy of Oral Immunotherapy to Pistachio in Children on the Oral Tolerance to Pistachio and Cashew Nuts
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Jan 1, 2023
• Actual Study Completion Date: Jan 16, 2023

Outcome Measures

Primary Outcome Measures

1. Absence of moderate to severe allergic reactions [during the 6 months of maintenance]

   with daily intake of 2g of pistachio

Secondary Outcome Measures

1. 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)]

2. 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)]

3. 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

4. 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

5. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalo-Universitaire de Nancy	Vandœuvre-lès-Nancy		France	54511

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

• Principal Investigator: Amandine DIVARET-CHAUVEAU, Centre hospitalo-universitaire de Nancy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amandine DIVARET-CHAUVEAU, MCU-PH, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT05698030
• Other Study ID Numbers: 2022PI182
• First Posted: Jan 26, 2023
• Last Update Posted: Jan 26, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypersensitivity; Food Hypersensitivity

Study Results

No Results Posted as of Jan 26, 2023