Food Challenge With Barley Starch as Active Comparator (BALA)

• ClinicalTrials.gov Identifier: NCT03352856
• Recruitment Status: Suspended
• First Posted: November 24, 2017
• Last Update Posted: March 5, 2019
• Sponsor: Lyckeby Starch AB
• Collaborators: FinnMedi Oy; Oy Medfiles Ltd
• Information provided by (Responsible Party): Lyckeby Starch AB

Study Description

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 Design

• 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, 2020
• Estimated Study Completion Date: March 31, 2021

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

• Responsible Party: Lyckeby Starch AB
• ClinicalTrials.gov Identifier: NCT03352856
• Other Study ID Numbers: MF20142700/BALA
• First Posted: November 24, 2017
• Last Update Posted: March 5, 2019
• 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; Immune System Diseases; Hypersensitivity, Immediate