Sublingual Immunotherapy for Food Allergy

Stopped early · Not applicable

Conditions studied: Food Allergies

In brief

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.

Key facts

Study ID

NCT00736281

Run by

University of Missouri-Columbia

People needed

31

Starts

2008-10-01

Expected to finish

2016-06-01

Last updated by the study team

2016-06-17

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic, reproducible symptoms following meals.
• Multiple food allergies where dietary avoidance is nearly impossible.
• Patients age 4 and older.
• Testing to verify food allergies is positive.

You may not qualify if…

• History of anaphylaxis, angioedema, asthma, or life-endangering reactions to certain food products.
• Children under the age of 4.
• Previous attempts to treat food allergy (subcutaneous injections).
• General medical condition that precludes elective therapy (including pregnancy).
• Inability to follow food allergy SLIT regimen.
• Autoimmune Disease.
• Chronic use of steroids.

Where it is running

• University Hospital: Department of Otolaryngology - Head and Neck Surgery — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.