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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
40
Highly purified barley starch
Maize starch
Tampere University Hospital
Tampere, Finland
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.
Time frame: 12-24 days (including 2 blinded challenges)
Severity of atopic dermatitis according to SCORAD-index
Worsening of atopic dermatitis
Time frame: 12-24 days (including 2 blinded challenges)
Symptom diary
Subjective symptoms based on diary
Time frame: 12-24 days (including 2 blinded challenges)
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