Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads

University of Hohenheim

Status

Enrolling

Conditions

Non-celiac Gluten Sensitivity

Wheat Hypersensitivity

Treatments

Other: Wheat bread

Study type

Interventional

Funder types

Other

Identifiers

NCT06152445

ErnMed-Brot-2022

Details and patient eligibility

About

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.

Full 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 0.5% to 13%.

Due to the lack of validated diagnostic criteria and/or 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.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age ≥18 ≤75 years
Signed declaration of consent
Willingness to adhere to the prescribed diet for the duration of the study
Chronic gastrointestinal symptoms for at least 6 months
Anamnestic wheat sensitivity
No acute or chronic gastrointestinal diseases (e.g. celiac disease / wheat allergy)
No or stable medication for at least 3 months
No participation in another clinical trial (current or within the past 30 days)

Exclusion criteria

Taking intestinal therapeutics, antibiotics, immunosuppressants, anti-allergic medication or similar
Pregnancy / lactation
Occurrence of relevant diseases (possibly individual decision)
Revocation of consent
Concurrent participation in another clinical study

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

64 participants in 5 patient groups, including a placebo group

Gluten free bread

Placebo Comparator group

Description: