NCT01755884

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

5.5 years

First QC Date

December 19, 2012

Last Update Submit

March 19, 2015

Conditions

Wheat Allergy

Keywords

Wheat allergyImmunotherapyDesensitizationFood allergyT cells

Outcome Measures

Primary Outcomes (1)

  • Efficacy of oral wheat desensitization

    Change in the tolerance to wheat and the amount of daily use of wheat in 3 months after the 5 months oral desensitization therapy.

    8 months

Secondary Outcomes (6)

  • Efficacy of oral wheat desensitization at 17 months

    17 months

  • Safety of oral wheat desensitization therapy at 8 months

    8 months

  • Safety of oral wheat desensitization therapy at 17 months

    17 months

  • Effect of the treatment on the characteristics and function of immune cells

    17 months

  • Effect of the treatment on the cell specific mRNA expression

    17 months

  • +1 more secondary outcomes

Study Arms (1)

Wheat oral immunotherapy

EXPERIMENTAL

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

Interventions

Wheat oral immunotherapyDIETARY_SUPPLEMENT

Cooked spaghetti

Wheat oral immunotherapy

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Helsinki University Central Hospital

Helsinki, Helsinki, 00029, Finland

Location

Kuopio University Hospital

Kuopio, Kuopio, 70211, Finland

Location

University of Oulu

Oulu, Oulu, 90014, Finland

Location

Tampere University Hospital

Tampere, Pirkanmaa, 33521, Finland

Location

MeSH Terms

Conditions

Wheat HypersensitivityFood Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Mika J Mäkelä, MD, PhD

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 24, 2012

Study Start

August 1, 2009

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

FI(4)