Oral Desensitization to Wheat in School Aged Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Helsinki University Central Hospital
Sponsor:
Collaborators:
University of Oulu
Oulu University Hospital
Tampere University Hospital
Kuopio University Hospital
Information provided by (Responsible Party):
Mika Juhani Mäkelä, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01755884
First received: December 19, 2012
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Wheat Allergy
Dietary Supplement: Wheat oral immunotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Desensitization to Wheat in Children Over 6 Years of Age With Wheat Allergy

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Efficacy of oral wheat desensitization [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Change in the tolerance to wheat and the amount of daily use of wheat in 3 months after the 5 months oral desensitization therapy.


Secondary Outcome Measures:
  • Efficacy of oral wheat desensitization at 17 months [ Time Frame: 17 months ] [ Designated as safety issue: No ]
    Change in the tolerance to wheat and the amount of daily use of wheat in 1 year after the 5 months oral desensitization therapy.

  • Safety of oral wheat desensitization therapy at 8 months [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events as a measure of tolerability and safety at 3 months after the 5 months desensitization therapy

  • Safety of oral wheat desensitization therapy at 17 months [ Time Frame: 17 months ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events as a measure of tolerability and safety at 1 year after the 5 months desensitization therapy

  • Effect of the treatment on the characteristics and function of immune cells [ Time Frame: 17 months ] [ Designated as safety issue: No ]
    Flow cytometric characterization of the change in the proportions of various T cell subtypes and in the function of these cells in in vitro proliferation and suppression tests between the samples taken before the treatment and 3 and 12 months after the treatment.

  • Effect of the treatment on the cell specific mRNA expression [ Time Frame: 17 months ] [ Designated as safety issue: No ]
    qRT-PCR measurement of the change in the expression level of T cell subtype specific mRNA levels between the samples taken before the treatment and 3 and 12 months after the treatment.

  • Effect of the treatment on the cytokine profile [ Time Frame: 17 months ] [ Designated as safety issue: No ]
    Flow cytometric measurement of the change in the levels of T cell subtype specific cytokine levels between the samples taken before the treatment and 3 and 12 months after the treatment.


Estimated Enrollment: 100
Study Start Date: August 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wheat oral immunotherapy
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.
Dietary Supplement: Wheat oral immunotherapy
Cooked spaghetti

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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elevated serum wheat specific IgE
  • Immediate reaction in open oral wheat challenge test
  • Diet free from wheat, rye, and barley

Exclusion Criteria:

  • Uncontrolled asthma
  • Other lung disease
  • Cardiovascular disease or other significant systemic disease
  • Patients having poor compliance
  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: NCT01755884

Contacts
Contact: Petri Kulmala, MD, PhD +358-8-3155534 petri.kulmala@oulu.fi
Contact: Mika J Mäkelä, MD, PhD +358-9-47186305 mika.makela@hus.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00029
Contact: Mika J Mäkelä, MD, PhD    +358-9.47186305    mika.makela@hus.fi   
Contact: Anna Pelkonen, MD, PhD    +358-9-47169116    anna.pelkonen@hus.fi   
Principal Investigator: Mika J Mäkelä, MD, PhD         
Principal Investigator: Anna Pelkonen, MD, PhD         
Principal Investigator: Mikael Kuitunen, MD, PhD         
Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Sami Remes, MD, PhD    +358-17-173 311    sami.remes@kuh.fi   
Principal Investigator: Sami Remes, MD, PhD         
University of Oulu Recruiting
Oulu, Finland, 90014
Contact: Petri Kulmala, MD, PhD    +358-8-3155534    petri.kulmala@oulu.fi   
Contact: Teija Dunder, MD, PhD    +358-9-3155301    teija.dunder@oulu.fi   
Principal Investigator: Petri Kulmala, MD, PhD         
Sub-Investigator: Teija Dunder, MD, PhD         
Sub-Investigator: Tiina Kirveskoski, MSc         
Sub-Investigator: Sami Turunen, MD         
Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Marita Paassilta, MD, PhD    +358-3-31167849    marita.paassilta@pshp.fi   
Principal Investigator: Marita Paassilta, MD, PhD         
Sponsors and Collaborators
Helsinki University Central Hospital
University of Oulu
Oulu University Hospital
Tampere University Hospital
Kuopio University Hospital
Investigators
Principal Investigator: Mika J Mäkelä, MD, PhD Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Mika Juhani Mäkelä, MD, PhD, Chief Physician, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01755884     History of Changes
Other Study ID Numbers: ODEW
Study First Received: December 19, 2012
Last Updated: June 14, 2013
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by Helsinki University Central Hospital:
Wheat allergy
Immunotherapy
Desensitization
Food allergy
T cells

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

ClinicalTrials.gov processed this record on October 20, 2014