Clinical trial NCT03234764: Longitudinal Follow-up Study for Food Allergies
Official title: Longitudinal Follow-up Study for Food Allergies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy
Keywords: IgE
Allergy
Tolerance
Immunotherapy
Desensitization
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 166
Sex: ALL
Minimum age (years): 6
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who underwent immunotherapy in clinical trial at the Sean N. Parker Center

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients ages 6 months through 70 years who have previously undergone a food immunotherapy protocol only at our center.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Immunological markers
timeFrame: February 2027
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Andorf 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.