Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome
Not Applicable
Completed
- Conditions
- Irritable Bowel Syndrome
- Registration Number
- NCT02161120
- Lead Sponsor
- Oy Karl Fazer Ab
- Brief Summary
The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-, Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than commonly available traditional rye bread higher in FODMAP carbohydrates. The study also aims to investigate patients' compliance to rye bread regimen, potential changes is gut microbiota and hydrogen production during the test periods (a marker of large bowel fermentation of poorly absorbed carbohydrates).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
- IBS according to Rome III criteria. Accepted sub-types include IBS-M, IBS-D and IBS-U
- Age 18-65 years
- Willing to use rye bread daily during the study periods
Exclusion Criteria
- IBS-C (constipation dominant)
- Celiac disease
- IBD
- Major gastrointestinal operations like bowel gastric resection
- Non-treated hypo- or hyperthyroidism
- Alcoholism, severe depression, dementia, cancer or other diseases likely to severly impair the participants ability to conclude the protocol
- Regular (almost daily) use of NSAIDs, antibiotics or lactulose
- Linaclotide and other prescription medicines targeted specifically to IBS
- Pregnancy and lactation
- Follows currently strict low-FODMAP diet
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change is IBS symptoms by using IBS-SSS questionaire 4 weeks
- Secondary Outcome Measures
Name Time Method IBS quality of life by using IBS QoL questionnaire 4 weeks Changes in specific IBS symptoms measured by 100 mm VAS scale 4 weeks Changes is intestinal microbiota evaluated by fecal samples 4 weeks Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast 4 weeks
Trial Locations
- Locations (1)
Aava Medical Centre
🇫🇮Helsinki, Finland
Aava Medical Centre🇫🇮Helsinki, Finland