Longitudinal Follow-up Study for Food Allergies

February 14, 2018 updated by: Sharon Chinthrajah, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

166

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who underwent immunotherapy in clinical trial at the Sean N. Parker Center

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological markers
Time Frame: February 2027
IgE, IgG4, T cells
February 2027

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 18, 2017

Study Completion (Actual)

December 18, 2017

Study Registration Dates

First Submitted

July 26, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 31, 2017

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36616

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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