MedTrace Logo

Food Challenge With Barley Starch as Active Comparator

NCT03352856 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-03-05

No results posted yet for this 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.

Conditions

  • Allergy;Food
  • Allergy Wheat

Interventions

OTHER

Barley starch

Highly purified barley starch

OTHER

Maize starch

Maize starch

Sponsors & Collaborators

  • FinnMedi Oy

    collaborator INDUSTRY

  • Oy Medfiles Ltd

    collaborator INDUSTRY

  • Lyckeby Starch AB

    lead INDUSTRY

Principal Investigators

  • Marita Paassilta, MD, Docent · Tampere University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
1 Year
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • Finland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03352856 on ClinicalTrials.gov