Efficacy and Saffety of Oral Immunotherapy to Pistachio | NCT05698030

Studies
Efficacy and Saffety of Oral Immunotherapy to Pistachio

NCT05698030

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Jan 26, 2023Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Allergy
Food Allergy

Interventions

Food allergy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Jan 16, 2023Actual

First Submitted Date

Jan 16, 2023

First Submission Date that Met QC Criteria

Jan 16, 2023

First Posted Date

Jan 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2023

Last Update Posted Date

Jan 26, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
Food allergy	Other	Oral immunotherapy to pistachio

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absence of moderate to severe allergic reactions	with daily intake of 2g of pistachio	during the 6 months of maintenance

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amandine DIVARET-CHAUVEAU	Centre hospitalo-universitaire de Nancy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalo-Universitaire de Nancy		Vandœuvre-lès-Nancy		54511	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity
D005512	Food Hypersensitivity

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided