Food Challenge With Barley Starch as Active Comparator (BALA)

Randomized, Double-blind, Placebo Controlled Food Challenge for the Assessment of Non-allergenicity of Refined Barley Starch in Cereal Allergic Patients

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 Overview

• Status: Suspended
• Conditions: Allergy;Food; Allergy Wheat
• Intervention / Treatment: Other: Barley starch; Other: Maize starch

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33520
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12-24 days (including 2 blinded challenges)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of atopic dermatitis according to SCORAD-index	Worsening of atopic dermatitis	12-24 days (including 2 blinded challenges)
Symptom diary	Subjective symptoms based on diary	12-24 days (including 2 blinded challenges)

Collaborators and Investigators

• Sponsor: Lyckeby Starch AB
• Collaborators: FinnMedi Oy; Oy Medfiles Ltd
• Investigators: Principal Investigator: Marita Paassilta, MD, Docent, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Cereal allergy; barley starch, DBPC
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: MF20142700/BALA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No