Food Challenge With Barley Starch as Active Comparator (BALA)
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|ClinicalTrials.gov Identifier: NCT03352856|
Recruitment Status : Suspended (Recruitment challenges)
First Posted : November 24, 2017
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Allergy;Food Allergy Wheat||Other: Barley starch Other: Maize starch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Double-blind, cross-over, randomly allocated, placebo controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Randomized, Double-blind, Placebo Controlled Food Challenge for the Assessment of Non-allergenicity of Refined Barley Starch in Cereal Allergic Patients|
|Actual Study Start Date :||October 13, 2017|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||March 31, 2021|
Active Comparator: Active
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.
Other: Barley starch
Highly purified barley starch
Placebo Comparator: Placebo
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.
Other: Maize starch
- 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.
- Severity of atopic dermatitis according to SCORAD-index [ Time Frame: 12-24 days (including 2 blinded challenges) ]Worsening of atopic dermatitis
- Symptom diary [ Time Frame: 12-24 days (including 2 blinded challenges) ]Subjective symptoms based on diary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352856
|Tampere University Hospital|
|Tampere, Finland, 33520|
|Principal Investigator:||Marita Paassilta, MD, Docent||Tampere University Hospital|