Food AllergyNCT03234764
Longitudinal Follow-up Study for Food Allergies
An observational study of Food Allergy, run by Stanford University.
Trial summary
The purpose of this study is to evaluate the clinical usefulness of assessing specific human allergy antibodies and other immunologic parameters associated with the diagnosis, evolution, and management of allergic disease. Read more about this study
- Who is it for?
- Ages 6 months to 70 years
- Conditions the study is for
- Food Allergy
- What is being tested?
- Immunotherapy
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 18 Dec 2017
- 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 6 months to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants who underwent immunotherapy in clinical trial at the Sean N. Parker Center
Who may be able to join
- Patients ages 6 months through 70 years who have previously undergone a food immunotherapy protocol only at our center.
Who cannot join
- None. However, if a participant becomes pregnant, their clinic visit may be postponed until after delivery and/or lactation period. These subject can postpone visits for one year and choose to skip visits during pregnancy and another year after (if breastfeeding).
About this study
The purpose of this study is to evaluate the clinical usefulness of assessing specific human allergy antibodies and other immunologic parameters associated with the diagnosis, evolution, and management of allergic disease.
Read the detailed description
The purpose of this study is to strengthen our ability to understand the long-term effects of food immunotherapy on the immune system and how it may induce tolerance to foods that participants were once allergic to. Investigators hope to determine tools and immunologic parameters that can help predict sustained desensitization and tolerance to food allergens following food immunotherapy. By evaluating the in-depth characteristics of allergy antibody populations and other immunologic parameters and comparing them to clinical disease, the investigators may uncover a more sound way to diagnose, follow and treat food allergic disease over time. Investigators will follow up with participants who underwent immunotherapy to food allergens as volunteers in clinical trials at the Sean N. Parker Center and assess whether they experience sustained desensitization to these foods in the long-term. Investigators will investigate the properties of the participants' immune cells and how they are affected over time by the ingestion of these food allergens. Investigators will follow the significance of different dosing regimens in terms of achieving tolerance. Differences in immune cell characteristics and other biological parameters may help predict the nature of a participant's tolerance to the food allergens and may help in the development of tools to determine permanent tolerance.
- Conditions
- Food Allergy
- Being tested
- Immunotherapy
- Keywords
- IgE, Allergy, Tolerance, Immunotherapy, Desensitization
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunotherapyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological markers
IgE, IgG4, T cells
Measured: February 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Mar 2016
- Primary completion18 Dec 2017
- Study completion18 Dec 2017
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.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Chinthrajah, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03234764
- Sponsor's protocol ID
- 36616
- Status last verified
- Feb 2018
- First submitted
- 26 Jul 2017
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. Allergy Asthma Clin Immunol. 2017 Dec 21;13:51. doi: 10.1186/s13223-017-0223-8. eCollection 2017.
PubMed 29296107Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Feasibility of sustained response through long-term dosing in food allergy immunotherapy. Allergy Asthma Clin Immunol. 2017 Dec 21;13:52. doi: 10.1186/s13223-017-0224-7. eCollection 2017.
PubMed 29296108
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Follow-up Study for Food Allergies
- ClinicalTrials.gov ID
- NCT03234764
- Acronym / sponsor ID
- 36616
- Conditions
- Food Allergy
- Keywords
- IgE, Allergy, Tolerance, Immunotherapy, Desensitization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 18 Dec 2017 (actual)
- Study completion
- 18 Dec 2017 (actual)
- First posted
- 31 Jul 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 study is to evaluate the clinical usefulness of assessing specific human allergy antibodies and other immunologic parameters associated with the diagnosis, evolution, and management of allergic disease.
Detailed description
The purpose of this study is to strengthen our ability to understand the long-term effects of food immunotherapy on the immune system and how it may induce tolerance to foods that participants were once allergic to. Investigators hope to determine tools and immunologic parameters that can help predict sustained desensitization and tolerance to food allergens following food immunotherapy. By evaluating the in-depth characteristics of allergy antibody populations and other immunologic parameters and comparing them to clinical disease, the investigators may uncover a more sound way to diagnose, follow and treat food allergic disease over time. Investigators will follow up with participants who underwent immunotherapy to food allergens as volunteers in clinical trials at the Sean N. Parker Center and assess whether they experience sustained desensitization to these foods in the long-term. Investigators will investigate the properties of the participants' immune cells and how they are affected over time by the ingestion of these food allergens. Investigators will follow the significance of different dosing regimens in terms of achieving tolerance. Differences in immune cell characteristics and other biological parameters may help predict the nature of a participant's tolerance to the food allergens and may help in the development of tools to determine permanent tolerance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who underwent immunotherapy in clinical trial at the Sean N. Parker Center
Key inclusion criteria (1 listed)
- Patients ages 6 months through 70 years who have previously undergone a food immunotherapy protocol only at our center.
Key exclusion criteria (1 listed)
- None. However, if a participant becomes pregnant, their clinic visit may be postponed until after delivery and/or lactation period. These subject can postpone visits for one year and choose to skip visits during pregnancy and another year after (if breastfeeding).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunotherapy | Other | – |
Primary outcome
Immunological markers
Time frame: February 2027
IgE, IgG4, T cells
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 19 Feb 2018.
- Background: PubMed 29296107Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Observational long-term follow-up study of rapid food oral immunotherapy with omalizumab. Allergy Asthma Clin Immunol. 2017 Dec 21;13:51. doi: 10.1186/s13223-017-0223-8. eCollection 2017.
- Background: PubMed 29296108Andorf S, Manohar M, Dominguez T, Block W, Tupa D, Kshirsagar RA, Sampath V, Chinthrajah RS, Nadeau KC. Feasibility of sustained response through long-term dosing in food allergy immunotherapy. Allergy Asthma Clin Immunol. 2017 Dec 21;13:52. doi: 10.1186/s13223-017-0224-7. eCollection 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy, run by Stanford University.
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 1 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Immunological markers (time frame: February 2027). 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 NCT03234764, 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 19 Feb 2018.