Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152445
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-11-13
Brief Title:
Wheat Bread Study Comparison of the Tolerance of Different Wheat Breads
Sponsor:
University of Hohenheim
Organization:
University of Hohenheim
Study Overview
Official Title:
Assessing the Tolerability of Different Types of Wheat Breads in Patients With Suspected Wheat Sensitivity
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to assess the differences in tolerability of differently manufactured wheat breads in a target group of individuals with suspected wheat sensitivity Additionally it will be verified if the absence of a response to oral exposure to defined bread types is associated with an absence of mucosal changes following CLE-assisted mucosal provocation with bread
Detailed Description:
Nowadays more than 20 of people in industrialized countries suffer from a food intolerance or food allergy with wheat and gluten intolerances on the rise Besides the well-known conditions celiac disease and wheat allergy another clinical entity called non-celiac wheat sensitivity NCWS was described which is not yet widely understood Resulting from inconsistent diagnostic criteria the prevalence of NCWS varies from 05 to 13
Due to the lack of validated diagnostic criteria andor appropriate biomarkers for diagnosis of NCWS it can currently only be suspected by exclusion of other diseases To verify suspected NCWS a double-blind placebo-controlled food challenge with wheat is recommended A confocal laser endomicroscopy CLE with endoluminal provocation can also provide meaningful results on the individual intestinal mucosal response to specific allergens
Furthermore it is as yet unclear whether NCWS is triggered by gluten FODMAPs or other wheat components such as α-amylase trypsin inhibitors Bread manufacturing processes can influence the composition of bread and the presence of possible triggers of intolerance reactions
This study aims to investigate the tolerability of differently manufactured wheat breads in individuals with suspected NCWS Additionally we expect this approach to improve the currently inadequate diagnosis of NCWS as well as to provide a better understanding of the underlying mechanisms
Therefore individuals with suspected NCWS are included in the trial Five different types of bread will be tested including 3 differently manufactured wheat breads a gluten free bread and a gluten free bread with added wheat flour Aim of this part is to test a possible psychological factor in NCWS symptoms
Due to the lack of validated diagnostic criteria andor appropriate biomarkers for diagnosis of NCWS it can currently only be suspected by exclusion of other diseases To verify suspected NCWS a double-blind placebo-controlled food challenge with wheat is recommended A confocal laser endomicroscopy CLE with endoluminal provocation can also provide meaningful results on the individual intestinal mucosal response to specific allergens
Furthermore it is as yet unclear whether NCWS is triggered by gluten FODMAPs or other wheat components such as α-amylase trypsin inhibitors Bread manufacturing processes can influence the composition of bread and the presence of possible triggers of intolerance reactions
This study aims to investigate the tolerability of differently manufactured wheat breads in individuals with suspected NCWS Additionally we expect this approach to improve the currently inadequate diagnosis of NCWS as well as to provide a better understanding of the underlying mechanisms
Therefore individuals with suspected NCWS are included in the trial Five different types of bread will be tested including 3 differently manufactured wheat breads a gluten free bread and a gluten free bread with added wheat flour Aim of this part is to test a possible psychological factor in NCWS symptoms
Study Oversight
Has Oversight DMC:
None
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?:
None