Predictors of Positive Food Challenge

NCT02786914 | Unknown

• 1 other identifier: 235/14
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with suspected tree-nut or sesame allergy based on sensitization on skin-prick tests (SPT), will be assessed for allergy using component analysis and basophil activation test (BAT) and entered into oral immunotherapy (OIT). Component analysis and BAT will be repeated after completion of OIT. Patients with tree-nut or sesame allergy treated with the standard of care of elimination diet will serve as controls

Conditions

Oral Immunotherapy for Food Allergy

Outcome Measures

Primary Outcomes (1)

• Number of patients with positive food challenge to tree-nuts and sesame

  Determining the best diagnostic method that would predict a positive vs. negative oral food challenge in food sensitized patients

  1 year

Secondary Outcomes (2)

• Number of patients with decreased component reactivity for a particular tree-nut and for sesame following OIT

  2.5 years

• Number of patients with decreased component cross reactivity for a particular tree-nut and for sesame following OIT

  2.5 years

Eligibility Criteria

• Age: 4 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the pool of patients referred to our center for evaluation of food allergy. The investigators have a database of over 1200 food allergic patients (OFC+) that can be utilized to attain the recruitment goal.

You may qualify if:

• Patients aged 4-45 years old, with a positive SPT to tree-nuts (walnut, pecan, cashew, pistachio, hazelnut or almond) and/or sesame, and either a history of a reaction in the past year, a positive OFC, or patients refraining from tree-nut consumption.

You may not qualify if:

• A history of other numerous chronic inflammatory diseases, including inflammatory bowel disease and other autoimmune diseases.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

The institute of Allergy, Immunology and Pediatric Pulmonary Medicine, Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

Central Study Contacts

Arnon Elizur

CONTACT

+97289779820; elizura@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: June 1, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2020
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)