Food Allergy Challenge Diagnostic Study

NCT02606721 | Completed

• 1 other identifier: ORA-FA-001
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to correlate various diagnostic measurements taken during an escalating dose oral food challenge to the subject's response. This study will investigate whether non invasive objective biomarkers can indicate a positive response to an escalating dose OFC before a systemic reaction occurs.

Conditions

Food Hypersensitivity

Keywords

Food Hypersensitivity; Oral Food Challenge; Skin Prick Test; Food Biomarkers

Outcome Measures

Primary Outcomes (2)

• Correlation between objective biomarker measures and challenge outcome

  Correlation between imaging measurements taken before, during, and after oral food challenge to outcome of challenge

  Change from baseline at 15 minute intervals until completion of challenge (approximately 3 hours)

• Correlation between subjective biomarker measures and challenge outcome

  Correlation between symptom questionnaire taken before, during, and after oral food challenge to outcome of challenge

  Change from baseline at 15 minute intervals until completion of challenge (approximately 3 hours)

Study Arms (1)

Challenge Subjects

Male or female subjects aged 5 - 35 with suspected food allergy and an upcoming scheduled clinical food challenge

Eligibility Criteria

• Age: 5 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with suspected food allergy and scheduled upcoming oral food challenge will be recruited.

You may qualify if:

• Male or female of any race, aged 5 - 35 years with planned clinical oral food challenge;
• Have provided verbal and written informed consent. If under the age of 18, a parent/guardian must provide verbal and written informed consent;
• Be willing and able to follow instructions, including participation in study assessments, and can be present for the required study visits for the duration of the study;

You may not qualify if:

• Be unable to comply with all study parameters and procedures

Sponsors & Collaborators

• ORA, Inc.: lead
• Tufts Medical Center: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• John Leung, M.D.

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: November 17, 2015
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 2, 2018

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)