Allergy;FoodBALANCT03352856
Food Challenge With Barley Starch as Active Comparator
A study testing Barley starch and Maize starch in people with Allergy;Food and Allergy Wheat, run by Lyckeby Starch AB at 1 site in Finland.
Trial summary
Aim of the present study is to verify in a double-blind placebo controlled food challenge (DBPCFC) test that highly purified barley starch ingredient do not cause allergic reaction in subjects most potential to get allergic reaction due to ingredient. Read more about this study
- Who is it for?
- Ages 1 year to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy;Food, Allergy Wheat
- What is being tested?
- Barley starch and Maize starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 13 Oct 2017to 31 Mar 2021
- 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 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age = 1-20 years
- Diagnosed or suspected cereal allergy (at least to one of the following cereals wheat, barley or rye)
- Response to cereal proteins confirmed within 2 months in an oral food challenge (OFC)* OR response to cereal proteins confirmed in an OFC more than 2 months ago but clinically verifiable and documented ongoing cereal allergy at the time of inclusion OR diagnosis confirmed in an OFC with wheat performed as part of the study procedures.
- Voluntarily signed informed consent (including willingness to refrain from cereal containing foods for 1 week before intervention period and be exposed to cereal proteins in the test for eligibility)
Who cannot join
- Complex food allergy which make elimination diet impossible to accomplish
- Patients experiencing unstable or exacerbated atopic disease, such as asthma, atopic dermatitis (AD), urticaria, or allergic rhinitis.
- Diseases and conditions that might affect safety. Patients should not be challenged if they have chronic medical the event of anaphylaxis/treatment of anaphylaxis. Examples of such conditions include unstable angina pectoris, cardiac disease or dysrhythmias, severe chronic lung disease.
- Pregnancy should be ruled out by testing or based on history (e.g, before menarche) as appropriate
- Use of oral corticosteroids. Inhaled and topical steroids or anti-inflammatory medications, such as calcineurin inhibitors or leukotriene antagonists and b-agonists, used at the lowest doses possible and on an established schedule by using fixed doses of medication to maintain a low and stable baseline of atopic disease. Latter medication can usually be continued because their use is unlikely to significantly influence challenge outcomes and their withdrawal might result in exacerbations, affecting disease management and challenge interpretation.
- Use of antihistamines during the last 4 days before DBPC challenge or period of 5 half-lives of specific agent.
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- Prolonged high dose steroids, omalizumab, or possibly other new drugs to control atopic disease upon decision of investigator.
- Aspirin/nonsteroidal anti-inflammatory drugs, angiotensin converting enzyme inhibitors, alcohol, antacids and β-blockers upon the decision of the investigator
- Any chronic condition or its medication that affect immune system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo Controlled Food Challenge for the Assessment of Non-allergenicity of Refined Barley Starch in Cereal Allergic Patients
Aim of the present study is to verify in a double-blind placebo controlled food challenge (DBPCFC) test that highly purified barley starch ingredient do not cause allergic reaction in subjects most potential to get allergic reaction due to ingredient. Hypothesis is that none of the cereal (mostly primarily wheat) allergic subject recruited to the study will obtain allergic reaction neither to placebo nor to the test ingredient. Scoring of symptoms during the challenges will be based on PRACTALL.
- Conditions
- Allergy;Food, Allergy Wheat
- Being tested
- Barley starch, Maize starch
- Keywords
- Cereal allergy; barley starch, DBPC
- Medical subject headings
- Food Hypersensitivity, Wheat Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barley starchOther
Highly purified barley starch
Maize starchOther
Maize starch
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Highly purified barley starch packed in sachets; Increasing doses given at clinic as follows: 0.6 g, 2 g, 6 g and 18 g. If required, continued at home with 2 x 18 g daily for 5 days. Receives: Other: Barley starch |
| Placebo | Placebo comparator | Maize starch packed in sachets; Increasing doses given at clinic as follows: 0.6 g, 2 g, 6 g and 18 g. If required, continued at home with 2 x 18 g daily for 5 days. Receives: Other: Maize starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Challenge outcome according to PRACTALL -score
Allergic reaction to active or placebo. Scoring and decision making based on PRACTALL as defined by Sampson et al., J Allergy Clin Immunol. 2012 Dec;130(6):1260-74.
Measured: 12-24 days (including 2 blinded challenges)
Secondary outcomes (2)
Severity of atopic dermatitis according to SCORAD-index
Worsening of atopic dermatitis
Measured: 12-24 days (including 2 blinded challenges)
Symptom diary
Subjective symptoms based on diary
Measured: 12-24 days (including 2 blinded challenges)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start13 Oct 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Why it stopped: Recruitment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy;FoodStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, cross-over, randomly allocated, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lyckeby Starch AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FinnMedi Oy, Oy Medfiles Ltd
- Responsible party
- Sponsor
- Investigators
- Marita Paassilta, MD, Docent, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352856
- Sponsor's protocol ID
- MF20142700/BALA
- Acronym
- BALA
- Status last verified
- Nov 2018
- First submitted
- 2 Oct 2017
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo Controlled Food Challenge for the Assessment of Non-allergenicity of Refined Barley Starch in Cereal Allergic Patients
- ClinicalTrials.gov ID
- NCT03352856
- Acronym / sponsor ID
- BALA / MF20142700/BALA
- Conditions
- Allergy;Food, Allergy Wheat
- Keywords
- Cereal allergy; barley starch, DBPC
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment challenges
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lyckeby Starch ABIndustry (pharma, biotech, devices)
- Collaborators
- FinnMedi Oy, Oy Medfiles Ltd
- Study start
- 13 Oct 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 24 Nov 2017 (actual)
- 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.
Aim of the present study is to verify in a double-blind placebo controlled food challenge (DBPCFC) test that highly purified barley starch ingredient do not cause allergic reaction in subjects most potential to get allergic reaction due to ingredient. Hypothesis is that none of the cereal (mostly primarily wheat) allergic subject recruited to the study will obtain allergic reaction neither to placebo nor to the test ingredient. Scoring of symptoms during the challenges will be based on PRACTALL.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, cross-over, randomly allocated, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Other: Barley starchHighly purified barley starch packed in sachets; Increasing doses given at clinic as follows: 0.6 g, 2 g, 6 g and 18 g. If required, continued at home with 2 x 18 g daily for 5 days. |
| Placebo | Placebo comparator | Other: Maize starchMaize starch packed in sachets; Increasing doses given at clinic as follows: 0.6 g, 2 g, 6 g and 18 g. If required, continued at home with 2 x 18 g daily for 5 days. |
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age = 1-20 years
- Diagnosed or suspected cereal allergy (at least to one of the following cereals wheat, barley or rye)
- Response to cereal proteins confirmed within 2 months in an oral food challenge (OFC)* OR response to cereal proteins confirmed in an OFC more than 2 months ago but clinically verifiable and documented ongoing cereal allergy at the time of inclusion OR diagnosis confirmed in an OFC with wheat performed as part of the study procedures.
- Voluntarily signed informed consent (including willingness to refrain from cereal containing foods for 1 week before intervention period and be exposed to cereal proteins in the test for eligibility)
Key exclusion criteria (9 listed)
- Complex food allergy which make elimination diet impossible to accomplish
- Patients experiencing unstable or exacerbated atopic disease, such as asthma, atopic dermatitis (AD), urticaria, or allergic rhinitis.
- Diseases and conditions that might affect safety. Patients should not be challenged if they have chronic medical the event of anaphylaxis/treatment of anaphylaxis. Examples of such conditions include unstable angina pectoris, cardiac disease or dysrhythmias, severe chronic lung disease.
- Pregnancy should be ruled out by testing or based on history (e.g, before menarche) as appropriate
- Use of oral corticosteroids. Inhaled and topical steroids or anti-inflammatory medications, such as calcineurin inhibitors or leukotriene antagonists and b-agonists, used at the lowest doses possible and on an established schedule by using fixed doses of medication to maintain a low and stable baseline of atopic disease. Latter medication can usually be continued because their use is unlikely to significantly influence challenge outcomes and their withdrawal might result in exacerbations, affecting disease management and challenge interpretation.
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 |
|---|---|---|
| Barley starchHighly purified barley starch | Other | Active |
| Maize starchMaize starch | Other | Placebo |
Primary outcome
Challenge outcome according to PRACTALL -score
Time frame: 12-24 days (including 2 blinded challenges)
Allergic reaction to active or placebo. Scoring and decision making based on PRACTALL as defined by Sampson et al., J Allergy Clin Immunol. 2012 Dec;130(6):1260-74.
2 secondary outcomes
Severity of atopic dermatitis according to SCORAD-index
Time frame: 12-24 days (including 2 blinded challenges)
Symptom diary
Time frame: 12-24 days (including 2 blinded challenges)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Marita Paassilta, MD, Docent principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barley starch and Maize starch in people with Allergy;Food and Allergy Wheat, run by Lyckeby Starch AB at 1 site 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 4 inclusion and 9 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: paused, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Challenge outcome according to PRACTALL -score (time frame: 12-24 days (including 2 blinded challenges)). 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 5 Mar 2019.