Single Center Food Allergy Oral Immunotherapy Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01490177 |
Recruitment Status :
Completed
First Posted : December 12, 2011
Last Update Posted : November 26, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Immune System Diseases | Drug: Food proteins | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | N/A |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: One |
Drug: Food proteins
Oral ingestion of Food proteins |
- Number of adverse events in the treatment population [ Time Frame: 2 years ]
- Number of subjects who reach 2g or more of food flour [ Time Frame: 2 years ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 4 Years to 55 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Responsible Party: | Kari Christine Nadeau, Associate Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT01490177 |
Other Study ID Numbers: |
22871 |
First Posted: | December 12, 2011 Key Record Dates |
Last Update Posted: | November 26, 2015 |
Last Verified: | November 2015 |
Multiple food allergies |
Hypersensitivity Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |