Food HypersensitivityNCT02606721
Food Allergy Challenge Diagnostic Study
An observational study of Food Hypersensitivity, run by ORA, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 35 years
- Conditions the study is for
- Food Hypersensitivity
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects with suspected food allergy and scheduled upcoming oral food challenge will be recruited.
Who may be able to join
- 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;
Who cannot join
- Be unable to comply with all study parameters and procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Pilot Study Evaluating Various Diagnostic Measurements Taken During an Escalating Dose Oral Food Challenge to Patient Response
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.
Read the detailed description
Patients often discover their food allergies after consuming a given food and experiencing a subsequent allergic reaction. The majority of patients (75%) will then consult a food allergist for formal diagnosis and treatment information. With respect to patient quality of life, there is tremendous benefit in having a confirmed diagnosis of food allergy as often patients are unsure of the source of their reaction outside the office. Allergists will conduct a Skin Prick Test (SPT) and assess serum specific IgE levels to screen for specific food protein sensitivities. However, a positive response in SPT and specific IgE will confirm only sensitivity, and in more than 70% of cases patients that respond positively to SPT and specific IgE testing will NOT manifest an allergic response to food consumption. To address this issue, most food allergists will recommend an oral food challenge in a controlled setting to confirm the allergic response from consuming the suspected foods. The oral food challenge (OFC) consists of consuming escalating levels of the suspect food, (usually mixed in applesauce or controlled baked goods), until either a reaction manifests or until the challenge is complete with no reaction. The food challenge process poses significant risk to the patient. In 5% of cases, the patient experiences a severe allergic response which requires the use of epinephrine. These responses typically consist of severe reactions in GI or respiratory and arise from challenging patients with higher doses of food allergen then is necessary to prove a mild allergic response, which is directly linked to variability in diagnosis of a positive response, within subjects and within investigators.
The investigators hypothesize that measurements taken using minimally-invasive diagnostic tests during the course of an escalating-dose oral food challenge will be able to detect a positive response before a systemic reaction occurs in the patient and may be able to screen with individuals predisposed to EOE.
- Conditions
- Food Hypersensitivity
- Keywords
- Food Hypersensitivity, Oral Food Challenge, Skin Prick Test, Food Biomarkers
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Challenge Subjects | Male or female subjects aged 5 - 35 with suspected food allergy and an upcoming scheduled clinical food challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between objective biomarker measures and challenge outcome
Correlation between imaging measurements taken before, during, and after oral food challenge to outcome of challenge
Measured: 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
Measured: Change from baseline at 15 minute intervals until completion of challenge (approximately 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startMar 2016
- Primary completionSep 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center
- Responsible party
- Sponsor
- Investigators
- John Leung, M.D., Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606721
- Sponsor's protocol ID
- ORA-FA-001
- Status last verified
- May 2016
- First submitted
- 10 Nov 2015
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Pilot Study Evaluating Various Diagnostic Measurements Taken During an Escalating Dose Oral Food Challenge to Patient Response
- ClinicalTrials.gov ID
- NCT02606721
- Acronym / sponsor ID
- ORA-FA-001
- Conditions
- Food Hypersensitivity
- Keywords
- Food Hypersensitivity, Oral Food Challenge, Skin Prick Test, Food Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients often discover their food allergies after consuming a given food and experiencing a subsequent allergic reaction. The majority of patients (75%) will then consult a food allergist for formal diagnosis and treatment information. With respect to patient quality of life, there is tremendous benefit in having a confirmed diagnosis of food allergy as often patients are unsure of the source of their reaction outside the office. Allergists will conduct a Skin Prick Test (SPT) and assess serum specific IgE levels to screen for specific food protein sensitivities. However, a positive response in SPT and specific IgE will confirm only sensitivity, and in more than 70% of cases patients that respond positively to SPT and specific IgE testing will NOT manifest an allergic response to food consumption. To address this issue, most food allergists will recommend an oral food challenge in a controlled setting to confirm the allergic response from consuming the suspected foods. The oral food challenge (OFC) consists of consuming escalating levels of the suspect food, (usually mixed in applesauce or controlled baked goods), until either a reaction manifests or until the challenge is complete with no reaction. The food challenge process poses significant risk to the patient. In 5% of cases, the patient experiences a severe allergic response which requires the use of epinephrine. These responses typically consist of severe reactions in GI or respiratory and arise from challenging patients with higher doses of food allergen then is necessary to prove a mild allergic response, which is directly linked to variability in diagnosis of a positive response, within subjects and within investigators.
The investigators hypothesize that measurements taken using minimally-invasive diagnostic tests during the course of an escalating-dose oral food challenge will be able to detect a positive response before a systemic reaction occurs in the patient and may be able to screen with individuals predisposed to EOE.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Challenge Subjects | – | –Male or female subjects aged 5 - 35 with suspected food allergy and an upcoming scheduled clinical food challenge |
Who may qualify
- Ages
- 5 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects with suspected food allergy and scheduled upcoming oral food challenge will be recruited.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (1 listed)
- Be unable to comply with all study parameters and procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between objective biomarker measures and challenge outcome
Time frame: Change from baseline at 15 minute intervals until completion of challenge (approximately 3 hours)
Correlation between imaging measurements taken before, during, and after oral food challenge to outcome of challenge
Correlation between subjective biomarker measures and challenge outcome
Time frame: Change from baseline at 15 minute intervals until completion of challenge (approximately 3 hours)
Correlation between symptom questionnaire taken before, during, and after oral food challenge to outcome of challenge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Food Hypersensitivity
Active, not recruiting
Slow Multiallergen Oral Immunotherapy in Young Children
Food Allergy, Oral Immunotherapy for Food Allergy
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Immunotherapy for Curing Toddlers With Severe Food Allergy - a Paradigm Shift From Passive to Active Treatment With Multi-allergen Oral Immunotherapy
Food Allergy in Children
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Oral Immunotherapy for Children With Peanut Allergy
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Study of Oral Food Challenge Biomarkers (SAFER)
Allergy
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EPAP, Interviewstudy
Food Allergy, Food Allergy Peanut
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Leung, M.D. principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Hypersensitivity, run by ORA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between objective biomarker measures and challenge outcome (time frame: Change from baseline at 15 minute intervals until completion of challenge (approximately 3 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018; AzTrials last refreshed its copy on 28 Oct 2026.