Sublingual Immunotherapy for Food Allergy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Missouri-Columbia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00736281
First received: August 14, 2008
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Food Allergies
Other: Food Drops: Food Allergens (peptides)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Sublingual Immunotherapy for Food Allergy

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: October 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Placebo Food Drops
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.
Active Comparator: Food Drops
Group 2 (intervention group) will receive sublingual immunotherapy (escalation followed by maintenance) with vials containing glycerin and the previously diagnosed food allergens (peptides).
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of anaphylaxis, angioedema, asthma, or life-endangering reactions to certain food products.
  2. Children under the age of 4.
  3. Previous attempts to treat food allergy (subcutaneous injections).
  4. General medical condition that precludes elective therapy (including pregnancy).
  5. Inability to follow food allergy SLIT regimen.
  6. Autoimmune Disease.
  7. Chronic use of steroids.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00736281

Locations
United States, Missouri
University Hospital: Department of Otolaryngology - Head and Neck Surgery
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Kevin W Lollar, M.D. University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Kevin W. Lollar, M.D. (Principal Investigator), MU Department of Otolaryngology - Head and Neck Surgery
ClinicalTrials.gov Identifier: NCT00736281     History of Changes
Other Study ID Numbers: MU-ENT-1118937
Study First Received: August 14, 2008
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Sublingual Immunotherapy for Food Allergy
Food Drops for Food Allergy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on July 31, 2014