Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT03352856
Status:
SUSPENDED
Last Update Posted:
2019-03-05
First Post:
2017-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Food Challenge With Barley Starch as Active Comparator
Sponsor:
Lyckeby Starch AB
Organization:
Study Overview
Official Title:
Randomized, Double-blind, Placebo Controlled Food Challenge for the Assessment of Non-allergenicity of Refined Barley Starch in Cereal Allergic Patients
Status:
SUSPENDED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment challenges
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BALA
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: