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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: Clinical Trial NA study, sponsored by University of Missouri-Columbia.

NCT00736281 is a NA study that was terminated before completion, run by University of Missouri-Columbia. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 31 participants
Start Date 2008-10
Est. Completion 2016-06
Phase NA
University of Missouri-Columbia

291 total trials

Why NCT00736281 stopped before completion

NCT00736281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Food Drops: Food Allergens (peptides) is the first listed.

NCT00736281 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00736281's enrollment target sits among peer trials

31 1592nd of 2000 higher than 408 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00736281, the US trial registry maintained by the National Library of Medicine. NCT00736281 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.