Oral Immunotherapy for Wheat Allergy (Wheat OIT)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hugh.Sampson, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
First received: November 5, 2013
Last updated: April 14, 2015
Last verified: April 2015
This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.

Condition Intervention Phase
Wheat Allergy
Drug: Wheat OIT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Oral Immunotherapy for Wheat Allergy

Resource links provided by NLM:

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Percentage of desensitized participants (while on daily wheat OIT) as measured by the ability to consume at least 5923 mg of Vital Wheat Gluten after a 9923 mg wheat Oral Food Challenge (OFC) performed 1 year after initiating treatment. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 1544 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 5923 mg of wheat protein on a 9923 mg wheat OFC performed 1 year after initiating treatment.

Secondary Outcome Measures:
  • The percentage of subjects in the initial active treatment group who achieve ad-lib consumption of wheat as demonstrated by a 9923 mg Vital Wheat Gluten OFC 8-10 weeks after therapy discontinuation at the 2 year time point. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • The percentage of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. [ Time Frame: 44 Weeks ] [ Designated as safety issue: No ]
  • The percentage of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Incidence of all serious adverse events during the study. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: October 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Wheat OIT
Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol.
Drug: Wheat OIT
Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.
Other Name: Vital Wheat Gluten
Placebo Comparator: Placebo
Placebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol.
Drug: Wheat OIT
Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.
Other Name: Vital Wheat Gluten

Detailed Description:
Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.

Ages Eligible for Study:   4 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 4-30 years either sex, any race, any ethnicity
  • Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE >= 0.35 kUA/L
  • Positive baseline challenge to wheat (<= 1923 mg of vital wheat gluten)
  • Written informed consent from subject and/or parent/guardian
  • Written assent from all subjects as appropriate
  • All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

  • History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation
  • Known allergy to corn
  • Known celiac disease
  • Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
  • Active eosinophilic gastrointestinal disease in the past two years
  • Participation in any interventional study for the treatment of food allergy in the past 6 months
  • Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
  • Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
  • A burst of oral, IM or IV steroids of more than 2 days for an indication other than asthma in the past 1 month
  • Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
  • Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
  • Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
  • Use of investigational drug within 90 days or plan to use investigational drug during the study period
  • Pregnancy or lactation
  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: NCT01980992

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 100029
Sponsors and Collaborators
Study Chair: Hugh A Sampson, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Hugh A Sampson, MD Icahn School of Medicine at Mount Sinai
  More Information

No publications provided

Responsible Party: Hugh.Sampson, Dean for Translational Biomedical Sciences, Director, Jaffe Food Allergy Institute, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01980992     History of Changes
Other Study ID Numbers: GCO 11-0197  FAI001 
Study First Received: November 5, 2013
Last Updated: April 14, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Icahn School of Medicine at Mount Sinai:
Food Allergy
Wheat Allergy
Oral Immunotherapy

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

ClinicalTrials.gov processed this record on February 04, 2016