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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 : November 30, 2018
Sponsor:
Collaborators:
FinnMedi Oy
Oy Medfiles Ltd
Information provided by (Responsible Party):
Lyckeby Starch AB

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.

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
Allocation: Randomized
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, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Starch

Arm Intervention/treatment
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
Maize starch




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Severity of atopic dermatitis according to SCORAD-index [ Time Frame: 12-24 days (including 2 blinded challenges) ]
    Worsening of atopic dermatitis

  2. Symptom diary [ Time Frame: 12-24 days (including 2 blinded challenges) ]
    Subjective symptoms based on diary



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Ages Eligible for Study:   1 Year to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
Finland
Tampere University Hospital
Tampere, Finland, 33520
Sponsors and Collaborators
Lyckeby Starch AB
FinnMedi Oy
Oy Medfiles Ltd
Investigators
Principal Investigator: Marita Paassilta, MD, Docent Tampere University Hospital

Responsible Party: Lyckeby Starch AB
ClinicalTrials.gov Identifier: NCT03352856     History of Changes
Other Study ID Numbers: MF20142700/BALA
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lyckeby Starch AB:
Cereal allergy; barley starch, DBPC

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Wheat Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate