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Sublingual Immunotherapy for Food Allergy

NCT00736281 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-06-17

No results posted yet for this study

Summary

The questions proposed by this study are those of safety and efficacy.

1. Concerning safety: "Are sublingual food drops (SLIT) safe enough to be used for stimulation of natural immune suppression in patients with food allergies?"
2. Concerning efficacy: "Do the drops suppress food allergy enough for patients to eat previously allergic foods with little or no allergic reaction?"

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.

Conditions

  • Food Allergies

Interventions

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.

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Rebecca Schneider, M.S. · University of Missouri - Department of Otolaryngology - Head and Neck Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00736281 on ClinicalTrials.gov