Single Center Food Allergy Oral Immunotherapy Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01490177
First received: November 29, 2011
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Immune System Diseases
Drug: Food proteins
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Center, Phase I Food Allergy Oral Immunotherapy Study

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Number of adverse events in the treatment population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of subjects who reach 2g or more of food flour [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: One Drug: Food proteins
Oral ingestion of Food proteins
Other Name: Food proteins

  Eligibility

Ages Eligible for Study:   4 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490177

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01490177     History of Changes
Other Study ID Numbers: 22871
Study First Received: November 29, 2011
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Multiple food allergies

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

ClinicalTrials.gov processed this record on April 20, 2014