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Single Center Food Allergy Oral Immunotherapy Study

NCT ID: NCT01490177

Last Updated: 2015-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-04-30

Brief Summary

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The Primary Objective of the study is to develop a customized regimen for oral immunotherapy that reflects what the subject is allergic in a clinically significant way (i.e., the offending food allergen is defined as a food allergen with a positive skin test or positive specific IgE and a positive DBPCFC). Therefore, the investigators prefer that both single and multiple food allergy subjects are included in the study.

Detailed Description

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Conditions

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Immune System Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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One

Group Type EXPERIMENTAL

Food proteins

Intervention Type DRUG

Oral ingestion of Food proteins

Interventions

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Food proteins

Oral ingestion of Food proteins

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Moderate to severe peanut and/or egg and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old.
* Sensitivity to food allergen will be documented by a positive skin prick test result (see Appendix for details) or allergen specific ImmunoCAP IgE level with 7 kU/L as a lower limit of eligibility.

Exclusion Criteria

* No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers).
* Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma.
Minimum Eligible Age

4 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Kari Christine Nadeau

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Begin P, Winterroth LC, Dominguez T, Wilson SP, Bacal L, Mehrotra A, Kausch B, Trela A, Hoyte E, O'Riordan G, Seki S, Blakemore A, Woch M, Hamilton RG, Nadeau KC. Safety and feasibility of oral immunotherapy to multiple allergens for food allergy. Allergy Asthma Clin Immunol. 2014 Jan 15;10(1):1. doi: 10.1186/1710-1492-10-1.

Reference Type DERIVED
PMID: 24428859 (View on PubMed)

Other Identifiers

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22871

Identifier Type: -

Identifier Source: org_study_id