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

Assessing the Tolerability of Different Types of Wheat Breads in Patients With Suspected Wheat Sensitivity

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.

Study Overview

• Status: Recruiting
• Conditions: Non-celiac Gluten Sensitivity; Wheat Hypersensitivity
• Intervention / Treatment: Other: Wheat 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephan C Bischoff, Prof.Dr; Phone Number: 071145924101; Email: bischoff.stephan@uni-hohenheim.de
• Study Contact Backup: Name: Patricia P Petersen, M.Sc; Phone Number: 071145923622; Email: patricia.petersen@uni-hohenheim.de

Study Locations

• Germany
  • Baden-Württemberg
    • Stuttgart, Baden-Württemberg, Germany, 70599
      • Recruiting
      • Institute of Nutritional Medicine, University of Hohenheim
      • Contact: Stephan C Bischoff, Prof. Dr.; Phone Number: 0711 459 24101; Email: bischoff.stephan@uni-hohenheim.de
      • Contact: Patricia P Petersen, M.Sc.; Phone Number: 0711 459 23622; Email: patricia.petersen@uni-hohenheim.de
  • Schleswig Holstein
    • Lübeck, Schleswig Holstein, Germany, 23562
      • Recruiting
      • Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck
      • Contact: Christian Sina, Prof. Dr.; Phone Number: 0451 3101 8401; Email: christian.sina@uksh.de
      • Contact: Ina Hohensee, Dr.; Phone Number: 0451 3101 8424; Email: ina.hohensee@uksh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Gluten free bread; Bread will be eaten by the participants for 7 consecutive days	Other: Wheat bread; Different wheat breads
Active Comparator: Gluten free bread with added wheat flour; Bread will be eaten by the participants for 7 consecutive days	Other: Wheat bread; Different wheat breads
Experimental: Wheat bread with Yeast, short fermentation + bread improver; Bread will be eaten by the participants for 7 consecutive days	Other: Wheat bread; Different wheat breads
Experimental: Wheat bread with Yeast, long fermentation; Bread will be eaten by the participants for 7 consecutive days	Other: Wheat bread; Different wheat breads
Experimental: Wheat bread with Sourdough, long fermentation; Bread will be eaten by the participants for 7 consecutive days	Other: Wheat bread; Different wheat breads

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of IBS-SSS Total Score	IBS-SSS (Irritable Bowel Syndrome - Severity Scoring System) Total score will be assessed with a questionnaire. Severity of gastrointestinal symptoms is shown on a scale from 0 to 500, with values from 75 - < 175 indicating mild symptoms, 175 - 300 moderate symptoms and > 300 severe symptoms.	Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impairment of health-related quality of life assessed by FAQLQ-AF	The impairment of wheat hypersensitivity on quality of life will be assessed with the Food Allergy Quality of Life Questionnaires - Adult Form (FAQLQ-AF). Level of Impairment is shown on a scale from 0 to 35, with higher values indicating severe impairment.	Study examinations are at baseline, after wash out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)
Intestinal permeability	Change of blood, urine and fecal markers to assess intestinal permeability and inflammation after oral administration of bread (Zonulin, LBP, Calprotectin, EDN).	Study examinations are at baseline, after wash out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)
Intestinal inflammation	Change of blood and fecal markers to assess intestinal inflammation after oral administration of bread (Calprotectin, EDN).	Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)
Metabolic alterations	Change in the plasma, urine and fecal metabolome after oral administration of bread (amino acids, biogenic amines)	Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Collaborators: University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: CLE; Human Nutrition; NCWS; Wheat Bread
• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Wheat Hypersensitivity
• Other Study ID Numbers: ErnMed-Brot-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No