Food Challenge With Barley Starch as Active Comparator

Allergy;Food Clinical Trial

— BALA  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03352856
• Other study ID #: MF20142700/BALA
• Status: Suspended
• Phase: N/A
• Start date: October 13, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: November 2018
• Source: Lyckeby Starch AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: March 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

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 ß-blockers upon the decision of the investigator

• Any chronic condition or its medication that affect immune system

Related Conditions & MeSH terms

• Allergy Wheat
• Allergy;Food
• Food Hypersensitivity
• Hypersensitivity
• Wheat Hypersensitivity

Intervention

Other:
• Barley starch
Highly purified barley starch
• Maize starch
Maize starch

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Lyckeby Starch AB	FinnMedi Oy, Oy Medfiles Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Severity of atopic dermatitis according to SCORAD-index	Worsening of atopic dermatitis	12-24 days (including 2 blinded challenges)
Secondary	Symptom diary	Subjective symptoms based on diary	12-24 days (including 2 blinded challenges)