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Completed

NCT Number: NCT01490177

Single Center Food Allergy Oral Immunotherapy Study

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.

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Key information

Conditions

Immune System Diseases

Age range

4 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Food proteins

Drug

Oral ingestion of Food proteins

Primary outcomes

  1. Number of adverse events in the treatment population

    Time frame: 2 years

Secondary outcomes

  1. Number of subjects who reach 2g or more of food flour

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Single Center, Phase I Food Allergy Oral Immunotherapy Study

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2011
Registry last updated
Nov 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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