Non-celiac Gluten SensitivityNCT06152445
Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads
A study testing Wheat bread in people with Non-celiac Gluten Sensitivity and Wheat Hypersensitivity, run by University of Hohenheim at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-celiac Gluten Sensitivity, Wheat Hypersensitivity
- What is being tested?
- Wheat bread
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 2 sitesGermany
- Study dates
- 19 Apr 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, 23562
Christian Sina, Prof. Dr., 0451 3101 8401, christian.sina@uksh.de
Ina Hohensee, Dr., 0451 3101 8424, ina.hohensee@uksh.de
- Recruiting
Institute of Nutritional Medicine, University of Hohenheim
Stuttgart, Baden-Wurttemberg, 70599
Stephan C Bischoff, Prof. Dr., 0711 459 24101, bischoff.stephan@uni-hohenheim.de
Patricia P Petersen, M.Sc., 0711 459 23622, patricia.petersen@uni-hohenheim.de
About this study
Official title: 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.
Read the 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.
- Being tested
- Wheat bread
- Keywords
- Human Nutrition, NCWS, Wheat Bread, CLE
- Medical subject headings
- Wheat Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat breadOther
Different wheat breads
| Study group | Role | What they receive |
|---|---|---|
| Gluten free bread | Placebo comparator | Bread will be eaten by the participants for 7 consecutive days Receives: Other: Wheat bread |
| Gluten free bread with added wheat flour | Active comparator | Bread will be eaten by the participants for 7 consecutive days Receives: Other: Wheat bread |
| Wheat bread with Yeast, short fermentation + bread improver | Experimental | Bread will be eaten by the participants for 7 consecutive days Receives: Other: Wheat bread |
| Wheat bread with Yeast, long fermentation | Experimental | Bread will be eaten by the participants for 7 consecutive days Receives: Other: Wheat bread |
| Wheat bread with Sourdough, long fermentation | Experimental | Bread will be eaten by the participants for 7 consecutive days Receives: Other: Wheat bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start19 Apr 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-celiac Gluten SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein
- Responsible party
- Principal investigator, Stephan C. Bischoff, MD, Professor, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152445
- Sponsor's protocol ID
- ErnMed-Brot-2022
- Status last verified
- May 2024
- First submitted
- 13 Nov 2023
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Tolerability of Different Types of Wheat Breads in Patients With Suspected Wheat Sensitivity
- ClinicalTrials.gov ID
- NCT06152445
- Acronym / sponsor ID
- ErnMed-Brot-2022
- Keywords
- Human Nutrition, NCWS, Wheat Bread, CLE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gluten free bread | Placebo comparator | Other: Wheat breadBread will be eaten by the participants for 7 consecutive days |
| Gluten free bread with added wheat flour | Active comparator | Other: Wheat breadBread will be eaten by the participants for 7 consecutive days |
| Wheat bread with Yeast, short fermentation + bread improver | Experimental | Other: Wheat breadBread will be eaten by the participants for 7 consecutive days |
| Wheat bread with Yeast, long fermentation | Experimental | Other: Wheat breadBread will be eaten by the participants for 7 consecutive days |
| Wheat bread with Sourdough, long fermentation | Experimental | Other: Wheat breadBread will be eaten by the participants for 7 consecutive days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheat breadDifferent wheat breads | Other | Gluten free bread, Gluten free bread with added wheat flour, Wheat bread with Sourdough, long fermentation, Wheat bread with Yeast, long fermentation, Wheat bread with Yeast, short fermentation + bread improver |
Primary outcome
Change of IBS-SSS Total Score
Time frame: Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6).
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.
4 secondary outcomes
Impairment of health-related quality of life assessed by FAQLQ-AF
Time frame: Study examinations are at baseline, after wash out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)
Intestinal permeability
Time frame: Study examinations are at baseline, after wash out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)
Intestinal inflammation
Time frame: Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)
Metabolic alterations
Time frame: Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat bread in people with Non-celiac Gluten Sensitivity and Wheat Hypersensitivity, run by University of Hohenheim at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephan C Bischoff, Prof.Dr (071145924101, bischoff.stephan@uni-hohenheim.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of IBS-SSS Total Score (time frame: Study examinations are at baseline, after wash-out phases (week 1, 3, 5) and after bread intervention phases (week 2, 4, 6).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.