Clinical Trial: Sublingual Immunotherapy for Food Allergy
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Sublingual Immunotherapy for Food Allergy
Brief Summary:
The questions proposed by this study are those of safety and efficacy.
- Concerning safety: "Are sublingual food drops (SLIT) safe enough to be used for stimulation of natural immune suppression in patients with food allergies?"
- 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
Detailed Summary:
Design:
Randomized-controlled blinded trial to evaluate the safety and efficacy of sublingual immunotherapy for food allergy sufferers. The study will report any adverse events caused by the administration of food allergy drops. Food allergy can manifest itself in many forms including general fatigue, abdominal pain, GERD, nausea, and other symptoms.
End Points:
Comparison between groups 1 and 2 about patient-reported adverse, as well as beneficial, events while on food allergy immunotherapy at 3, 6, 9, 12 months after maintenance dose is achieved (SLIT questionnaire). These comparisons relate to both safety and efficacy issues.
Methodology:
Trial subjects will be identified by their presenting complaints due to ingestion of certain symptomatic foods. Clinical assessment of potential food allergy participants for SLIT will occur according to usual testing standards. All participants will have diagnostic tests (usually RAST analysis and or food challenge techniques) to confirm specific food allergies. Subjects who meet the inclusion criteria will be asked to participate in the study through informed consent. Once consent has been obtained, the subject will be randomly assigned to either the control or the intervention group.
Group 1 (control group) will receive sublingual immunotherapy (escalation followed by maintenance) with vials containing glycerin.
Group 2 (intervention group) will receive sublingual immunotherapy (escalation followed by maintenance) with vials containing glycerin and the previously diagnosed food allergens.
Sponsor: University of Missouri-Columbia
Current Primary Outcome: Validated Questionnaires will be administered to trial participants at 3, 6, 9, 12 months after achieving the maintenance dose of food drops. [ Time Frame: safety and efficacy questionnaires administered at 3, 6, 9, 12 months after achieving the maintenance dose of food drops ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Missouri-Columbia
Dates:
Date Received: August 14, 2008
Date Started: October 2008
Date Completion:
Last Updated: June 16, 2016
Last Verified: June 2016
