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Single Center Food Allergy Oral Immunotherapy Study

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ClinicalTrials.gov Identifier: NCT01490177
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : November 26, 2015
Sponsor:
Information provided by (Responsible Party):
Kari Christine Nadeau, Stanford University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Immune System Diseases Drug: Food proteins Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Center, Phase I Food Allergy Oral Immunotherapy Study
Study Start Date : November 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: One Drug: Food proteins
Oral ingestion of Food proteins


Outcome Measures
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Primary Outcome Measures :
  1. Number of adverse events in the treatment population [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Number of subjects who reach 2g or more of food flour [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490177


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kari Christine Nadeau, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01490177     History of Changes
Other Study ID Numbers: 22871
First Posted: December 12, 2011    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015

Keywords provided by Kari Christine Nadeau, Stanford University:
Multiple food allergies

Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate