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NCT00736281 · ClinicalTrials.gov registry record · NA
Sublingual Immunotherapy for Food Allergy
A NA study, sponsored by University of Missouri-Columbia.
- Terminated
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT00736281 is a NA study that was terminated before completion, run by University of Missouri-Columbia. The registered enrollment target is 31 participants.
The verdict
NCT00736281, a NA study, was terminated before completion, sponsored by University of Missouri-Columbia.
- TERMINATED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
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.
Interventions
- OTHER Food Drops: Food Allergens (peptides)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2008-10 |
| Est. Completion | 2016-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00736281
The ClinicalTrials.gov registry entry for NCT00736281 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Food Drops: Food Allergens (peptides) is the first listed.
NCT00736281 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00736281 about?
NCT00736281 is a clinical study titled "Sublingual Immunotherapy for Food Allergy". 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 fo...
What is the current status of trial NCT00736281?
This trial is currently terminated. It is a NA study. The enrollment target is 31 participants. The study started on 2008-10. Estimated completion is 2016-06.
What interventions are being tested in trial NCT00736281?
The interventions under investigation include: Food Drops: Food Allergens (peptides) (OTHER).
Who is sponsoring clinical trial NCT00736281?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
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