K58
Conditions
Interventions
Group 1: one-week gluten-free run-in period, first one-week bread phase (low-FODMAP wheatbread, 130 g daily), one-week wash-out Phase, second one-week bread phase (regular wheatbread, 130 g daily)
Gro
Sponsors
Institut für Ernährungsmedizin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Sufficient knowledge of the German language to understand the study documents and the information materials for implementation of the gluten-free diet • Irritable bowel syndrome diagnosis according to the Rome-III-criteria or RDS-like symptoms excluding other intestinal diseases
Exclusion criteria
Exclusion criteria: • Pregnancy, person in lactation • Diagnosis of other functional bowel diseases such as celiac disease, wheat allergy or inflammatory bowel disease • Alcohol addiction • Intake of medicines that affect the gastrointestinal tract, e.g. Antidiarrheals and proton pump inhibitors • Intake of antibiotics and/or probiotics during the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the end of each bread phase, changes in the irritable bowel syndrome (IBS)-severity during the FODMAP-reduced wheat phase compared to the regular wheat phase are determined using the IBS-Severity Scoring System (IBS-SSS) via a visual analogue scale (VAS). | — |
Secondary
| Measure | Time frame |
|---|---|
| At the beginning and at the end of the 1st, 2nd, 3rd and 4th week, changes in severity of intestinal and extraintestinal symptoms are analyzed individually and overall using VAS. At the same time points, quality of life using the EQ-5D-5L questionnaire are determined as well as the microbiome by stool sample analysis. | — |
Countries
Germany
Contacts
Public ContactKatharina Schlumm
Institut für Ernährungsmedizin
Outcome results
None listed