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SuspendedNCT03352856BALAUpdated Mar 5, 2019

Food Challenge With Barley Starch as Active Comparator

An interventional study of Barley starch and Maize starch in Allergy;Food and Allergy Wheat, sponsored by Lyckeby Starch AB. Suspended at 1 site in Finland. Open to participants aged 1 Year to 20 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-05.

Primary conditionWheat HypersensitivityRegistry: Food HypersensitivityReclassifiedWhy we changed it
Registry
Food Hypersensitivity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Wheat Hypersensitivity
Why
  1. The study's listed conditions name Wheat Hypersensitivity, a narrower term within Food Hypersensitivity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Lyckeby Starch AB · Not applicable, Interventional, and Basic science

Why this study was suspended
Recruitment challenges
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
1 Year to 20 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Allergy;Food
  • Allergy Wheat

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Keywords

  • Cereal allergy; barley starch, DBPC
03

In context

Wheat Hypersensitivity Reclassified

20 studies on the registry are indexed under Wheat Hypersensitivity; 5 are open to participants now.

This study's planned enrollment of 40 is below the median of 46 across 14 interventional studies indexed under Wheat Hypersensitivity.

Browse Wheat Hypersensitivity studies →

Lead sponsor

This is the only study on the registry with Lyckeby Starch AB as lead sponsor.

Compared within Wheat Hypersensitivity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Food Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
1 Year to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (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

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 . 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • OtherBarley starch

    Highly purified barley starch

  • OtherMaize starch

    Maize starch

06

What researchers measure

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.

    Time frame: 12-24 days (including 2 blinded challenges)

Secondary outcomes

  1. Severity of atopic dermatitis according to SCORAD-index

    Worsening of atopic dermatitis

    Time frame: 12-24 days (including 2 blinded challenges)

  2. Symptom diary

    Subjective symptoms based on diary

    Time frame: 12-24 days (including 2 blinded challenges)

07

Study locations

1 site
  • Tampere University Hospital
    Tampere, 33520, Finland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2017 (actual). Primary completion is estimated for Dec 2020, 38 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2017
First posted
Nov 24, 2017
StartActual
Oct 13, 2017
Primary completionEst.
Dec 31, 2020
CompletionEst.
Mar 31, 2021
Last update
Mar 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03352856
Lead sponsor
Lyckeby Starch AB
Collaborators
FinnMedi Oy, Oy Medfiles Ltd
Responsible party
Sponsor
First posted
Nov 24, 2017
Start date
Oct 13, 2017
Primary completion
Dec 31, 2020 (estimated)
Completion
Mar 31, 2021 (estimated)
Last update
Mar 5, 2019

Study contacts

Marita Paassilta, MD, Docent
principal investigator · Tampere University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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