NCT06152445

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 19, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

November 13, 2023

Last Update Submit

May 16, 2024

Conditions

Non-celiac Gluten SensitivityWheat Hypersensitivity

Keywords

Human NutritionNCWSWheat BreadCLE

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Impairment of health-related quality of life assessed by FAQLQ-AF

    Study examinations are at baseline, after wash out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)

  • Intestinal permeability

    Study examinations are at baseline, after wash out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)

  • Intestinal inflammation

    Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)

  • Metabolic alterations

    Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)

Study Arms (5)

Gluten free bread

PLACEBO COMPARATOR

Bread will be eaten by the participants for 7 consecutive days

Other: Wheat bread

Gluten free bread with added wheat flour

ACTIVE COMPARATOR

Bread will be eaten by the participants for 7 consecutive days

Other: Wheat bread

Wheat bread with Yeast, short fermentation + bread improver

EXPERIMENTAL

Bread will be eaten by the participants for 7 consecutive days

Other: Wheat bread

Wheat bread with Yeast, long fermentation

EXPERIMENTAL

Bread will be eaten by the participants for 7 consecutive days

Other: Wheat bread

Wheat bread with Sourdough, long fermentation

EXPERIMENTAL

Bread will be eaten by the participants for 7 consecutive days

Other: Wheat bread

Interventions

Wheat breadOTHER

Different wheat breads

Gluten free breadGluten free bread with added wheat flourWheat bread with Sourdough, long fermentationWheat bread with Yeast, long fermentationWheat bread with Yeast, short fermentation + bread improver

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Nutritional Medicine, University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

RECRUITING

Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

RECRUITING

MeSH Terms

Conditions

Wheat Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Stephan C Bischoff, Prof.Dr

CONTACT

071145924101bischoff.stephan@uni-hohenheim.de

Patricia P Petersen, M.Sc

CONTACT

071145923622patricia.petersen@uni-hohenheim.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Dr. med.

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 30, 2023

Study Start

April 19, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

DE(2)