Food AllergyNCT02070263
Mixed Tree Nut Food Challenges
An observational study of Food Allergy, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this prospective study is twofold: 1) to establish oral tolerance to selected tree nuts and to examine potential predictors of oral tolerance and 2) to determine the usefulness of mixed tree nut allergen food challenges in more efficiently defining tree nut allergy and oral tolerance. Read more about this study
- Who is it for?
- Ages 3 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2020
- 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 3 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients seen at Arkansas Children's Hospital between 3-21 years of age who have tree nut food allergies.
Who may be able to join
- Any patient between 3-21 years of age followed by the Allergy and Immunology Department at Arkansas Children's Hospital on tree nut avoidance diet.
- Has current serum IgE test within the past 12 months to major nuts in question. All TN serum IgE are <10
- Children must have a stable baseline examination prior to undergoing challenge without significant symptoms of atopic dermatitis, allergic rhinoconjunctivitis, current urticaria or other allergic symptoms deemed important by the physician.
- Children must have stable asthma and no wheezing or repetitive cough prior to challenge, nor have been treated with oral steroids for a significant asthma exacerbation within 1 month of challenge. Asthmatics that undergo lung function testing.
- Children must have no current illness (e.g., fever or viral illness) at time of challenge.
- The subject will be asked to restrict the use of antihistamines (short acting, 72 hours: long acting, 5-7 days), (B-agonists (12 hours), theophylline (12 hours), and cromolyn (12 hours) prior to the first mixed TN food challenge. Other medications may be continued.
Who cannot join
- Any TN serum IgE ≥10.
- Life-threatening reaction (respiratory involvement requiring medications, or shock, or gastrointestinal reaction requiring intravenous fluids) to any TN.
- History of a reaction in the past year or severe reaction in the past 2 years or a history of a severe reaction anytime with a TN serum IgE >5
- Unstable asthma, gastrointestinal disease, cardiovascular disease, chronic lung disease, beta-blocker use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
The purpose of this prospective study is twofold: 1) to establish oral tolerance to selected tree nuts and to examine potential predictors of oral tolerance and 2) to determine the usefulness of mixed tree nut allergen food challenges in more efficiently defining tree nut allergy and oral tolerance.
Read the detailed description
To evaluate the absence of tree nuts (TN) allergy, referred patients from one of the Arkansas Children's Hospital (ACH) Allergy Clinic physicians with current serum immunoglobulin E (IgE) to TNs that meet eligibility criteria will be invited to undergo a series of open mixed TN food challenges.
A questionnaire pertaining to their TN allergy will be administered
A brief physical exam will be performed.
Skin prick tests using selected nut allergen extracts along with a positive (histamine) and a negative (salt-water) control will be performed at the first oral food challenge visit.
Each food challenges will be performed to 1 to 3 TNs.
Two telephone follow-up phone calls will evaluate inclusion/exclusion of tree nuts in the diet post food challenge.
- Conditions
- Food Allergy
- Keywords
- Food allergy, Tree nuts
- Medical subject headings
- Food Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral tolerance to selected tree nuts (TN) to determine potential predictors of oral tolerance.
This prospective, observational study uses serum IgE to specific TN, skin prick test to TN, and TN oral food challenges to establish oral tolerance.
Measured: total -20 years
Secondary outcomes (1)
Use of tree nut (TN) IgE testing to assess the risk of positive food challenges based on grouped mixed TN food challenges
We postulate that by grouping TN that are mixed into one food challenge based on the individual's TN serum IgE will be more efficient in defining TN allergy and tolerance. One to three TNs will be in one food challenge based on TN IgE testing.
Measured: total - 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startApr 2009
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacie M Jones, MD, Principal investigator, University of Arkansas for Medical Sciences / Arkansas Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070263
- Sponsor's protocol ID
- 110035
- Status last verified
- Jan 2019
- First submitted
- 8 Aug 2013
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Data has not been analyzed at thistime
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixed Tree Nut Food Challenges
- ClinicalTrials.gov ID
- NCT02070263
- Acronym / sponsor ID
- 110035
- Conditions
- Food Allergy
- Keywords
- Food allergy, Tree nuts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Feb 2014 (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 purpose of this prospective study is twofold: 1) to establish oral tolerance to selected tree nuts and to examine potential predictors of oral tolerance and 2) to determine the usefulness of mixed tree nut allergen food challenges in more efficiently defining tree nut allergy and oral tolerance.
Detailed description
To evaluate the absence of tree nuts (TN) allergy, referred patients from one of the Arkansas Children's Hospital (ACH) Allergy Clinic physicians with current serum immunoglobulin E (IgE) to TNs that meet eligibility criteria will be invited to undergo a series of open mixed TN food challenges.
A questionnaire pertaining to their TN allergy will be administered
A brief physical exam will be performed.
Skin prick tests using selected nut allergen extracts along with a positive (histamine) and a negative (salt-water) control will be performed at the first oral food challenge visit.
Each food challenges will be performed to 1 to 3 TNs.
Two telephone follow-up phone calls will evaluate inclusion/exclusion of tree nuts in the diet post food challenge.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients seen at Arkansas Children's Hospital between 3-21 years of age who have tree nut food allergies.
Key inclusion criteria (6 listed)
- Any patient between 3-21 years of age followed by the Allergy and Immunology Department at Arkansas Children's Hospital on tree nut avoidance diet.
- Has current serum IgE test within the past 12 months to major nuts in question. All TN serum IgE are <10
- Children must have a stable baseline examination prior to undergoing challenge without significant symptoms of atopic dermatitis, allergic rhinoconjunctivitis, current urticaria or other allergic symptoms deemed important by the physician.
- Children must have stable asthma and no wheezing or repetitive cough prior to challenge, nor have been treated with oral steroids for a significant asthma exacerbation within 1 month of challenge. Asthmatics that undergo lung function testing.
- Children must have no current illness (e.g., fever or viral illness) at time of challenge.
Key exclusion criteria (4 listed)
- Any TN serum IgE ≥10.
- Life-threatening reaction (respiratory involvement requiring medications, or shock, or gastrointestinal reaction requiring intravenous fluids) to any TN.
- History of a reaction in the past year or severe reaction in the past 2 years or a history of a severe reaction anytime with a TN serum IgE >5
- Unstable asthma, gastrointestinal disease, cardiovascular disease, chronic lung disease, beta-blocker use.
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
Oral tolerance to selected tree nuts (TN) to determine potential predictors of oral tolerance.
Time frame: total -20 years
This prospective, observational study uses serum IgE to specific TN, skin prick test to TN, and TN oral food challenges to establish oral tolerance.
1 secondary outcome
Use of tree nut (TN) IgE testing to assess the risk of positive food challenges based on grouped mixed TN food challenges
Time frame: total - 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Individual participant dataSharing planned: Undecided. Data has not been analyzed at thistime
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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.
Stacie M Jones, MD principal investigator
University of Arkansas for Medical Sciences / Arkansas Children's Hospital
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 Allergy, run by Arkansas Children's Hospital Research Institute 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Jan 2019. 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?
Results are not available in the source record.
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?
Oral tolerance to selected tree nuts (TN) to determine potential predictors of oral tolerance. (time frame: total -20 years). 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 10 Jan 2019.