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| Sponsor: | University of Missouri-Columbia |
|---|---|
| Information provided by: | University of Missouri-Columbia |
| ClinicalTrials.gov Identifier: | NCT00736281 |
Purpose
The questions proposed by this study are those of safety and efficacy.
The aim of this trial is to provide systematic collection of data proving the safety and efficacy of food drops in the correction of food allergy. A patient's range of symptoms, which can include but are not limited to fatigue, nausea, vomiting, diarrhea, abdominal pain, and insomnia can be diagnostic indicators of food allergies.
An approach to answering the above questions can be done by a randomized, controlled, blinded study. The design of our study could be reasonable and powerful because this layout limits bias and accounts for placebo effects:
The patients enrolled in our study will present with food allergy symptoms and diagnostic tests will provide the specific information regarding their food allergies. Once the diagnosis has been made and consent for treatment has been obtained, participants will be randomly assigned to either the group that receives the food allergy intervention with SLIT ( food allergens mixed with 50% glycerin in a vial) or the group that receives the control SLIT (glycerin only). The patients are truly blinded to their treatment because all the SLIT food allergy vials are identical and contain no distinguishing features that could reveal their contents. There is also no difference in taste between a vial containing glycerin and food allergens and a vial containing only glycerin. Therefore, a food allergy SLIT randomized-controlled study can be reasonably achieved.
| Condition | Intervention |
|---|---|
|
Food Allergies |
Other: Food Drops: Food Allergens (peptides) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Sublingual Immunotherapy for Food Allergy |
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Placebo Food Drops
The patients enrolled in our study will present with food allergy symptoms and diagnostic tests will provide the specific information regarding their food allergies. Once the diagnosis has been made and consent for treatment has been obtained, participants will be randomly assigned to either the group that receives the food allergy intervention with SLIT ( food allergens mixed with 50% glycerin in a vial) or the group that receives the control SLIT (glycerin only). The patients are truly blinded to their treatment because all the SLIT food allergy vials are identical and contain no distinguishing features that could reveal their contents. There is also no difference in taste between a vial containing glycerin and food allergens and a vial containing only glycerin.
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Active Comparator: Food Drops
Group 2 (intervention group) will receive sublingual immunotherapy (escalation followed by maintenance) with vials containing glycerin and the previously diagnosed food allergens (peptides).
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Other: Food Drops: Food Allergens (peptides)
The patients enrolled in our study will present with food allergy symptoms and diagnostic tests will provide the specific information regarding their food allergies. Once the diagnosis has been made and consent for treatment has been obtained, participants will be randomly assigned to either the group that receives the food allergy intervention with SLIT ( food allergens mixed with 50% glycerin in a vial) or the group that receives the control SLIT (glycerin only). The patients are truly blinded to their treatment because all the SLIT food allergy vials are identical and contain no distinguishing features that could reveal their contents. There is also no difference in taste between a vial containing glycerin and food allergens and a vial containing only glycerin.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 4 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |
| University Hospital: Department of Otolaryngology - Head and Neck Surgery | |
| Columbia, Missouri, United States, 65212 | |
| Principal Investigator: | Kevin W Lollar, M.D. | University of Missouri-Columbia |
More Information
| Responsible Party: | Kevin W. Lollar, M.D. (Principal Investigator), MU Department of Otolaryngology - Head and Neck Surgery |
| ClinicalTrials.gov Identifier: | NCT00736281 History of Changes |
| Other Study ID Numbers: | MU-ENT-1118937 |
| Study First Received: | August 14, 2008 |
| Last Updated: | January 13, 2010 |
| Health Authority: | United States: Institutional Review Board |
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Sublingual Immunotherapy for Food Allergy Food Drops for Food Allergy |
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Hypersensitivity Food Hypersensitivity Immune System Diseases Hypersensitivity, Immediate |