Wheat AllergyNCT01755884
Oral Desensitization to Wheat in School Aged Children
A study testing Wheat oral immunotherapy in people with Wheat Allergy, run by Helsinki University Central Hospital at 4 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Wheat Allergy
- What is being tested?
- Wheat oral immunotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesFinland
- Study dates
- Aug 2009to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elevated serum wheat specific IgE
- Immediate reaction in open oral wheat challenge test
- Diet free from wheat, rye, and barley
Who cannot join
- Uncontrolled asthma
- Other lung disease
- Cardiovascular disease or other significant systemic disease
- Patients having poor compliance
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
Helsinki University Central Hospital
Helsinki, Helsinki, 00029
Kuopio University Hospital
Kuopio, Kuopio, 70211
University of Oulu
Oulu, Oulu, 90014
Tampere University Hospital
Tampere, Pirkanmaa, 33521
About this study
Official title: Oral Desensitization to Wheat in Children Over 6 Years of Age With Wheat Allergy
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.
Read the 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.
- Conditions
- Wheat Allergy
- Being tested
- Wheat oral immunotherapy
- Keywords
- Wheat allergy, Immunotherapy, Desensitization, Food allergy, T cells
- Medical subject headings
- Wheat Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat oral immunotherapyDietary supplement
Cooked spaghetti
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Wheat oral immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (6)
Efficacy of oral wheat desensitization at 17 months
Change in the tolerance to wheat and the amount of daily use of wheat in 1 year after the 5 months oral desensitization therapy.
Measured: 17 months
Safety of oral wheat desensitization therapy at 8 months
Number of participants with adverse events as a measure of tolerability and safety at 3 months after the 5 months desensitization therapy
Measured: 8 months
Safety of oral wheat desensitization therapy at 17 months
Number of participants with adverse events as a measure of tolerability and safety at 1 year after the 5 months desensitization therapy
Measured: 17 months
Effect of the treatment on the characteristics and function of immune cells
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.
Measured: 17 months
Effect of the treatment on the cell specific mRNA expression
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.
Measured: 17 months
Effect of the treatment on the cytokine profile
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.
Measured: 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startAug 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wheat AllergyStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital
- Responsible party
- Principal investigator, Mika Juhani Mäkelä, MD, PhD, Helsinki University Central Hospital
- Investigators
- Mika J Mäkelä, MD, PhD, Principal investigator, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755884
- Sponsor's protocol ID
- ODEW
- Status last verified
- Mar 2015
- First submitted
- 19 Dec 2012
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Desensitization to Wheat in Children Over 6 Years of Age With Wheat Allergy
- ClinicalTrials.gov ID
- NCT01755884
- Acronym / sponsor ID
- ODEW
- Conditions
- Wheat Allergy
- Keywords
- Wheat allergy, Immunotherapy, Desensitization, Food allergy, T cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Oulu, Oulu University Hospital, Tampere University Hospital, Kuopio University Hospital
- Study start
- Aug 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 24 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wheat oral immunotherapy | Experimental | Dietary Supplement: Wheat oral immunotherapyWell-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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Elevated serum wheat specific IgE
- Immediate reaction in open oral wheat challenge test
- Diet free from wheat, rye, and barley
Key exclusion criteria (4 listed)
- Uncontrolled asthma
- Other lung disease
- Cardiovascular disease or other significant systemic disease
- Patients having poor compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat oral immunotherapyCooked spaghetti | Dietary supplement | Wheat oral immunotherapy |
Primary outcome
Efficacy of oral wheat desensitization
Time frame: 8 months
Change in the tolerance to wheat and the amount of daily use of wheat in 3 months after the 5 months oral desensitization therapy.
6 secondary outcomes
Efficacy of oral wheat desensitization at 17 months
Time frame: 17 months
Safety of oral wheat desensitization therapy at 8 months
Time frame: 8 months
Safety of oral wheat desensitization therapy at 17 months
Time frame: 17 months
Effect of the treatment on the characteristics and function of immune cells
Time frame: 17 months
Effect of the treatment on the cell specific mRNA expression
Time frame: 17 months
Effect of the treatment on the cytokine profile
Time frame: 17 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mika J Mäkelä, MD, PhD principal investigator
Helsinki University Central Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat oral immunotherapy in people with Wheat Allergy, run by Helsinki University Central Hospital at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of oral wheat desensitization (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.