Oral Desensitization to Wheat in School Aged Children
Condition: Wheat Allergy
MeSH terms: Hypersensitivity; Wheat Hypersensitivity
Study type: Interventional

Summary: 
      The aim of the study is to induce tolerance to wheat in wheat allergic children via oral
      desensitization therapy. The hypothesis is that oral administration of wheat with increasing
      dosing will increase the individual threshold for allergic reactivity to wheat protein (i.e.
      desensitization) and even result in no reactivity (i.e. full tolerance). Along with this, the
      risk for severe allergic reaction to wheat protein is minimized and the diet of patients can
      partly or completely be normalized. In addition to clinical measures, the immunological
      mechanisms of desensitization therapy are studied in detail at cellular and molecular level.
    

Detailed description: 
      This is a prospective multicenter study investigating the efficacy, safety and immunological
      mechanisms of oral wheat desensitization therapy in school-aged (6-16 yrs of age) wheat
      allergic children. Wheat allergic children with avoidance diet, immediate reaction in a
      recent (less than 4 months) food challenge test for wheat and elevated serum wheat-specific
      IgE levels are recruited to the study. Patients having uncontrolled asthma, other lung
      disease, cardiovascular disease or other significant systemic disease and patients having
      poor compliance are excluded. Well-cooked wheat spaghetti is given daily to the patients
      starting from a minimal dosage (0,0003 g of wheat protein) and increasing the dosing in every
      1-2 weeks until a dosage corresponding the size of one meal. The initial dosage is given and
      certain defined dosage step-ups are carried out in the hospital outpatient clinic. The
      patient and parents are prepared for the emergency treatment of severe allergic reaction and
      carry adequate medication with them. The daily use of spaghetti continues with the received
      maintenance dosage for additional 3 months, until the clinical evaluation of the patient.
      Thereafter, the patients are allowed to use also other wheat products. Peripheral venous
      blood samples are taken before therapy and at 3 months and 1 year follow-up visits after
      reaching the maintenance dosage. The characteristics and function of isolated peripheral
      blood mononuclear cells (PBMC) will be specifically tested using flow cytometric methods. The
      expression levels of cell-specific mRNAs (messenger ribonucleic acid) and cytokines are
      measured with qRT-PCR (quantitative reverse transcriptase real-time polymerase chain
      reaction)and flow cytometry based methods. In addition, specific IgE (immunoglobulin E)
      levels are measured and serum samples are frozen for further testing. Two separate control
      groups are also recruited. The first group includes patients with previous food-challenge
      proven IgE-mediated wheat allergy with spontaneous recovery and the current free use of wheat
      protein in their diet. The second group includes children (6-16 yrs of age) who come to
      hospital for a minor surgical operation (e.g. minor trauma, circumcision, patellar luxation
      etc.). Children with asthma, allergy, atopic eczema, any other chronic disease or recent
      infection (less than 2 weeks ago) are excluded from this group. Peripheral venous blood
      samples are taken from all control children. The characteristics and function of isolated
      PBMCs, the expression levels of cell-specific mRNAs and cytokines and specific IgE levels are
      measured.
    

Intervention name(s): Wheat oral immunotherapy
Intervention type(s): Dietary Supplement
Intervention description(s): Cooked spaghetti
Intervention MeSH terms: Immunomodulating Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wheat allergy; Immunotherapy; Desensitization; Food allergy; T cells