Clinical trial NCT03352856: Food Challenge With Barley Starch as Active Comparator
Official title: Randomized, Double-blind, Placebo Controlled Food Challenge for the Assessment of Non-allergenicity of Refined Barley Starch in Cereal Allergic Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Allergy;Food
Allergy Wheat
Keywords: Cereal allergy; barley starch, DBPC
Lead sponsor: Lyckeby Starch AB
Sponsor class: INDUSTRY
Collaborators: name: FinnMedi Oy
name: Oy Medfiles Ltd
First posted: 2017-11-24
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, cross-over, randomly allocated, placebo controlled
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Challenge outcome according to PRACTALL -score
timeFrame: 12-24 days (including 2 blinded challenges)
Secondary outcomes:
measure: Severity of atopic dermatitis according to SCORAD-index
timeFrame: 12-24 days (including 2 blinded challenges)
measure: Symptom diary
timeFrame: 12-24 days (including 2 blinded challenges)
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Marita Paassilta, MD, Docent
role: PRINCIPAL_INVESTIGATOR
References: