Food AllergyNCT03059589
Registry of Food Allergy Oral Immunotherapy Treatment
An observational study of Food Allergy, run by Food Allergy Support Team at 1 site in United States.
Trial summary
The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Food Allergy
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2017to 31 Dec 2020
- How long will I take part?
- 4 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients presenting to participating clinical sites with high probability of food allergy who choose to undergo food oral immunotherapy treatment.
Who may be able to join
- a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food,
- no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food
Who cannot join
- pregnancy
- severe asthma
- poorly controlled atopic dermatitis
- eosinophilic esophagitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Registry of Food Allergy Treatment
The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.
Read the detailed description
Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.
- Conditions
- Food Allergy
- Keywords
- food anaphylaxis, peanut anaphylaxis, food oral immunotherapy, food allergy, food allergy treatment
- Medical subject headings
- Food Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of food allergy treatment
the percentage of patients who successfully reach the maintenance dose of food
Measured: 3 years
Secondary outcomes (2)
epinephrine use
The frequency of epinephrine use during the course of oral immunotherapy as reported in the prospective database. Also, identify factors that are associated with the need for epinephrine.
Measured: 3 years
factors associated with the failure to reach the target dose of food ingestion
Identify factors that are associated with treatment failures through analysis of patient demographics, baseline laboratory test results, and concomitant atopic conditions.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start15 Apr 2017
- Primary completion20 Aug 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Food Allergy Support Team
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugh Windom, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059589
- Sponsor's protocol ID
- Mylan-16-004
- Status last verified
- Feb 2021
- First submitted
- 13 Feb 2017
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wasserman RL, Factor JM, Baker JW, Mansfield LE, Katz Y, Hague AR, Paul MM, Sugerman RW, Lee JO, Lester MR, Mendelson LM, Nacshon L, Levy MB, Goldberg MR, Elizur A. Oral immunotherapy for peanut allergy: multipractice experience with epinephrine-treated reactions. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):91-6. doi: 10.1016/j.jaip.2013.10.001.
PubMed 24565775Nachshon L, Goldberg MR, Elizur A, Levy MB, Schwartz N, Katz Y. A Web site-based reporting system for monitoring home treatment during oral immunotherapy for food allergy. Ann Allergy Asthma Immunol. 2015 Jun;114(6):510-5. doi: 10.1016/j.anai.2015.04.007. Epub 2015 May 1.
PubMed 25940735
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of Food Allergy Treatment
- ClinicalTrials.gov ID
- NCT03059589
- Acronym / sponsor ID
- Mylan-16-004
- Conditions
- Food Allergy
- Keywords
- food anaphylaxis, peanut anaphylaxis, food oral immunotherapy, food allergy, food allergy treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Food Allergy Support TeamUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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 patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.
Detailed description
Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients presenting to participating clinical sites with high probability of food allergy who choose to undergo food oral immunotherapy treatment.
Key inclusion criteria (2 listed)
- a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food,
- no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food
Key exclusion criteria (4 listed)
- pregnancy
- severe asthma
- poorly controlled atopic dermatitis
- eosinophilic esophagitis
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
efficacy of food allergy treatment
Time frame: 3 years
the percentage of patients who successfully reach the maintenance dose of food
2 secondary outcomes
epinephrine use
Time frame: 3 years
factors associated with the failure to reach the target dose of food ingestion
Time frame: 3 years
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 4 Feb 2021.
- Background: PubMed 24565775Wasserman RL, Factor JM, Baker JW, Mansfield LE, Katz Y, Hague AR, Paul MM, Sugerman RW, Lee JO, Lester MR, Mendelson LM, Nacshon L, Levy MB, Goldberg MR, Elizur A. Oral immunotherapy for peanut allergy: multipractice experience with epinephrine-treated reactions. J Allergy Clin Immunol Pract. 2014 Jan-Feb;2(1):91-6. doi: 10.1016/j.jaip.2013.10.001.
- Background: PubMed 25940735Nachshon L, Goldberg MR, Elizur A, Levy MB, Schwartz N, Katz Y. A Web site-based reporting system for monitoring home treatment during oral immunotherapy for food allergy. Ann Allergy Asthma Immunol. 2015 Jun;114(6):510-5. doi: 10.1016/j.anai.2015.04.007. Epub 2015 May 1.
- Individual participant dataSharing planned: Undecided
Related trials for Food Allergy
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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.
Hugh Windom, MD principal investigator
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 Food Allergy Support Team 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 2 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: finished, as of the sponsor's last update on 4 Feb 2021. 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?
efficacy of food allergy treatment (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059589, which also lists 2 linked publications.
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 4 Feb 2021.