Food Challenge With Barley Starch as Active Comparator

NCT03352856 | Suspended

• 1 other identifier: MF20142700/BALA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy;Food; Allergy Wheat

Keywords

Cereal allergy; barley starch, DBPC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Severity of atopic dermatitis according to SCORAD-index

  12-24 days (including 2 blinded challenges)

• Symptom diary

  12-24 days (including 2 blinded challenges)

Study Arms (2)

Active

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Barley starch OTHER

Highly purified barley starch

Active

Maize starch OTHER

Maize starch

Placebo

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age = 1-20 years
• Diagnosed or suspected cereal allergy (at least to one of the following cereals wheat, barley or rye)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lyckeby Starch AB: lead
• FinnMedi Oy: collaborator
• Oy Medfiles Ltd: collaborator

Study Sites (1)

Tampere University Hospital

Tampere, 33520, Finland

Location

MeSH Terms

Conditions

Food Hypersensitivity; Wheat Hypersensitivity

Interventions

Starch

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Marita Paassilta, MD, Docent

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, cross-over, randomly allocated, placebo controlled

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: November 24, 2017
• Study Start: October 13, 2017
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2021
• Last Updated: March 5, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)