Food Hypersensitivity Clinical Trial
Official title:
An Exploratory Pilot Study Evaluating Various Diagnostic Measurements Taken During an Escalating Dose Oral Food Challenge to Patient Response
NCT number | NCT02606721 |
Other study ID # | ORA-FA-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | October 2016 |
Verified date | May 2016 |
Source | ORA, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | October 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 35 Years |
Eligibility |
Inclusion Criteria: - 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; Exclusion Criteria: - Be unable to comply with all study parameters and procedures |
Country | Name | City | State |
---|---|---|---|
United States | Tufts Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
ORA, Inc. | Tufts Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) |
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