Single Center Food Allergy Oral Immunotherapy Study
This study is ongoing, but not recruiting participants.
Sponsor:
Stanford University
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
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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 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 May 23, 2013