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Trial record 8 of 343 for:    "Food Allergy"

Longitudinal Follow-up Study for Food Allergies

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ClinicalTrials.gov Identifier: NCT03234764
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sharon Chinthrajah, Stanford University

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.

Condition or disease Intervention/treatment
Food Allergy Other: Immunotherapy

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.

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Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Follow-up Study for Food Allergies
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : December 18, 2017
Actual Study Completion Date : December 18, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Immunological markers [ Time Frame: February 2027 ]
    IgE, IgG4, T cells


Biospecimen Retention:   Samples With DNA
Blood Sputum Buccal swab Saliva Urine Stool


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who underwent immunotherapy in clinical trial at the Sean N. Parker Center
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).

Publications:
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Responsible Party: Sharon Chinthrajah, Clinical Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03234764     History of Changes
Other Study ID Numbers: 36616
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018
Keywords provided by Sharon Chinthrajah, Stanford University:
IgE
Allergy
Tolerance
Immunotherapy
Desensitization
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Immunologic Factors
Physiological Effects of Drugs