Sublingual Immunotherapy for Food Allergy

NCT00736281 | Terminated DMC

• 1 other identifier: MU-ENT-1118937
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The questions proposed by this study are those of safety and efficacy.

1. 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. 2.Concerning efficacy: "Do the drops suppress food allergy enough for patients to eat previously allergic foods with little or no allergic reaction?"

Conditions

Food Allergies

Keywords

Sublingual Immunotherapy for Food Allergy; Food Drops for Food Allergy

Outcome Measures

Primary Outcomes (1)

• Validated Questionnaires will be administered to trial participants at 3, 6, 9, 12 months after achieving the maintenance dose of food drops.

  safety and efficacy questionnaires administered at 3, 6, 9, 12 months after achieving the maintenance dose of food drops

Study Arms (2)

Placebo Food Drops

NO INTERVENTION

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.

Food Drops

ACTIVE COMPARATOR

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)

Interventions

Food Drops: Food Allergens (peptides) OTHER

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.

Food Drops

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital: Department of Otolaryngology - Head and Neck Surgery

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Peptides

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Rebecca Schneider, M.S.

  University of Missouri - Department of Otolaryngology - Head and Neck Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06

Locations

US (1)