Non-celiac Gluten Sensitivity Clinical Trial
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.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | June 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck | Lübeck | Schleswig Holstein |
Germany | Institute of Nutritional Medicine, University of Hohenheim | Stuttgart | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
University of Hohenheim | University Hospital Schleswig-Holstein |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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