Clinical TrialID 7910
Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads
NCT06152445
Non-celiac Gluten Sensitivity|Wheat Hypersensitivity
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7910
- Evidence Id
- 7910
- Core Evidence Id
- 7910
- Source Clinical Trial Id
- 7907
- Herb2 Clinical Trial Id
- HBCT007907
- Nct Id
- NCT06152445
- Title
- Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads
- Status
- Recruiting
- Phase
- Study Result
- No
- Study Condition
- Non-celiac Gluten Sensitivity|Wheat Hypersensitivity
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: SUPPORTIVE_CARE
- Intervention
- OTHER: Wheat bread
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Single
- Intervention Purpose
- Supportive_Care
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 64
- Outcome Measure
- 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).
- Sponsor Collaborator
- University of Hohenheim|University Hospital Schleswig-Holstein
- Funded By
- OTHER
- Location
- Institute of Nutritional Medicine, University of Hohenheim, Stuttgart, Baden-Württemberg, 70599, Germany|Institute of Nutritional Medicine, University Hospital Schleswig Holstein, Campus Lübeck, Lübeck, Schleswig Holstein, 23562, Germany
- Other Id
- ErnMed-Brot-2022
- Start Date
- 2023-04-19
- Primary Completion Date
- 2024-06
- Completion Date
- 2024-06
- First Posted
- 2023-11-30
- Results First Posted
- Last Update Posted
- 2024-05-17
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT06152445
- Title Cn
- Title En
- Wheat Bread Study: Comparison of the Tolerance of Different Wheat Breads
- Bilingual Status
- semi_complete