Food AllergyNCT01332084
Use of Hypoallergenic (H.A.) Cereals in Children With Diagnosed Allergy to Wheat
A study testing HA wheat cereals in people with Food Allergy, run by Société des Produits Nestlé (SPN) at 2 sites in Switzerland.
Trial summary
The investigators plan to launch a Specific Oral Tolerance Induction (SOTI) pilot study in order to assess the efficacy and the safety of hypoallergenic (H.A.) wheat cereals, for children with allergy to wheat. The study has the potential to offer a desensitization treatment option for children allergic to wheat. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- HA wheat cereals
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2011to Feb 2012
- 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 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant of any ethnicity aged between 1 to 12 years old at the time of enrollment and
- Positive Skin Prick Test (SPT) to wheat and/or Positive specific IgE to wheat and
- Immediate positive reaction (IgE-type reaction) to wheat as shown by provocation test done a maximum 1 year before the enrollment to the study or an unambiguous history for wheat allergy as evaluated by the investigator and
- Having obtained his/her signed legal representative's informed consent
Who cannot join
- Child on systemic drugs (potentially affecting the allergic reactions e.g. antihistamines) according to half-life at time of enrollment or
- Congenital illness or malformation that may affect normal growth (especially immunodeficiency) or
- Child with uncontrolled asthma or
- Child whose parents/caregivers cannot be expected to comply with treatment or
- Child currently participating in another interventional clinical trial.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Adult&Child Allergy Unit, HUG
Geneva, 1211
Unité d'immunologie, allergologie et rhumatologie pédiatrique Département médico-chirurgical de pédiatrie CHUV
Lausanne, 1011
About this study
Official title: Assessment of the Feasibility of a SOTI With Hypoallergenic (H.A.) Cereals in Children With Diagnosed IgE-mediated Allergy to Wheat
The investigators plan to launch a Specific Oral Tolerance Induction (SOTI) pilot study in order to assess the efficacy and the safety of hypoallergenic (H.A.) wheat cereals, for children with allergy to wheat. The study has the potential to offer a desensitization treatment option for children allergic to wheat.
The investigators hypothesize that H.A. wheat cereals have similar efficacy with less side effects than native wheat cereals.
Read the detailed description
In this pilot study, the investigators aim to assess the feasibility of a SOTI (Specific Oral Tolerance Induction) with hypoallergenic (H.A.) cereals in children with diagnosed IgE-Mediated allergy to wheat.
This is a multi centre, open, pilot study testing 1 product.10 children of any ethnicity aged from 1 to 12 years old with diagnosed allergy to wheat will be eligible to participate in the study. The duration of the treatment will be 6 months with a minimum of 1 month of daily consumption of the hydrolyzed wheat cereals.
Each subject will feed with a quantity of the assigned study product according to the SOTI. The SOTI will be performed at the hospital under the control of qualified doctors and nurses.
The study product is administered starting with very low dosages, which are increased stepwise every 30 minutes up to an amount equivalent to the usual daily oral intake. Thereafter, the study product corresponding to the maximum dose tolerated is given in a maintenance dose in one serve every day until the final visit during which a challenge test with wheat will be performed to assess the tolerance of whole wheat.
- Conditions
- Food Allergy
- Being tested
- HA wheat cereals
- Keywords
- SOTI, tolerance, desensitization, challenge test, HA wheat cereals
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA wheat cerealsOther
HA wheat cereals used in SOTI test and as part of desensitization plan
| Study group | Role | What they receive |
|---|---|---|
| hypoallergenic wheat cereals | Experimental | HA wheat cereal used in a SOTI test Receives: Other: HA wheat cereals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific Oral Tolerance Induction (SOTI) with hypoallergenic wheat in children allergic to wheat
The primary outcome is to document Clinical examination for presence or absence of immediate adverse reaction during the SOTI with evaluation of the maximum dose tolerated during the SOTI.
Symptoms related to allergic reactions during the SOTI (if applicable)will be recorded in the CRF.
Measured: 6 months
Secondary outcomes (1)
assess allergic reactions to a challenge test to wheat
challenge test will be performed at the end of the treatment with HA cereals. Other blood immunological parameters will be evaluated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Lauener, Prof MD, Principal investigator, Universitäts-Kinderklinik ZürichJacqueline Wassenberg, MD, Principal investigator, Département médico-chirurgical de pédiatrie, CHUV, LausannePhilippe Eigenmann, MD, Principal investigator, Adult&Child Allergy Unit, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332084
- Sponsor's protocol ID
- 09.19.INF
- Status last verified
- Jun 2012
- First submitted
- 6 Apr 2011
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Feasibility of a SOTI With Hypoallergenic (H.A.) Cereals in Children With Diagnosed IgE-mediated Allergy to Wheat
- ClinicalTrials.gov ID
- NCT01332084
- Acronym / sponsor ID
- 09.19.INF
- Conditions
- Food Allergy
- Keywords
- SOTI, tolerance, desensitization, challenge test, HA wheat cereals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Apr 2011 (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 investigators plan to launch a Specific Oral Tolerance Induction (SOTI) pilot study in order to assess the efficacy and the safety of hypoallergenic (H.A.) wheat cereals, for children with allergy to wheat. The study has the potential to offer a desensitization treatment option for children allergic to wheat.
The investigators hypothesize that H.A. wheat cereals have similar efficacy with less side effects than native wheat cereals.
Detailed description
In this pilot study, the investigators aim to assess the feasibility of a SOTI (Specific Oral Tolerance Induction) with hypoallergenic (H.A.) cereals in children with diagnosed IgE-Mediated allergy to wheat.
This is a multi centre, open, pilot study testing 1 product.10 children of any ethnicity aged from 1 to 12 years old with diagnosed allergy to wheat will be eligible to participate in the study. The duration of the treatment will be 6 months with a minimum of 1 month of daily consumption of the hydrolyzed wheat cereals.
Each subject will feed with a quantity of the assigned study product according to the SOTI. The SOTI will be performed at the hospital under the control of qualified doctors and nurses.
The study product is administered starting with very low dosages, which are increased stepwise every 30 minutes up to an amount equivalent to the usual daily oral intake. Thereafter, the study product corresponding to the maximum dose tolerated is given in a maintenance dose in one serve every day until the final visit during which a challenge test with wheat will be performed to assess the tolerance of whole wheat.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypoallergenic wheat cereals | Experimental | Other: HA wheat cerealsHA wheat cereal used in a SOTI test |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant of any ethnicity aged between 1 to 12 years old at the time of enrollment and
- Positive Skin Prick Test (SPT) to wheat and/or Positive specific IgE to wheat and
- Immediate positive reaction (IgE-type reaction) to wheat as shown by provocation test done a maximum 1 year before the enrollment to the study or an unambiguous history for wheat allergy as evaluated by the investigator and
- Having obtained his/her signed legal representative's informed consent
Key exclusion criteria (5 listed)
- Child on systemic drugs (potentially affecting the allergic reactions e.g. antihistamines) according to half-life at time of enrollment or
- Congenital illness or malformation that may affect normal growth (especially immunodeficiency) or
- Child with uncontrolled asthma or
- Child whose parents/caregivers cannot be expected to comply with treatment or
- Child currently participating in another interventional clinical trial.
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 |
|---|---|---|
| HA wheat cerealsHA wheat cereals used in SOTI test and as part of desensitization plan | Other | hypoallergenic wheat cereals |
Primary outcome
Specific Oral Tolerance Induction (SOTI) with hypoallergenic wheat in children allergic to wheat
Time frame: 6 months
The primary outcome is to document Clinical examination for presence or absence of immediate adverse reaction during the SOTI with evaluation of the maximum dose tolerated during the SOTI. Symptoms related to allergic reactions during the SOTI (if applicable)will be recorded in the CRF.
1 secondary outcome
assess allergic reactions to a challenge test to wheat
Time frame: 6 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 22 Jun 2012.
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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.
Roger Lauener, Prof MD principal investigator
Universitäts-Kinderklinik Zürich
Jacqueline Wassenberg, MD principal investigator
Département médico-chirurgical de pédiatrie, CHUV, Lausanne
Philippe Eigenmann, MD principal investigator
Adult&Child Allergy Unit, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA wheat cereals in people with Food Allergy, run by Société des Produits Nestlé (SPN) at 2 sites in Switzerland.
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 4 inclusion and 5 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 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Specific Oral Tolerance Induction (SOTI) with hypoallergenic wheat in children allergic to wheat (time frame: 6 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 22 Jun 2012; AzTrials last refreshed its copy on 8 Nov 2026.