Irritable Bowel Syndrome
Conditions
Keywords
IBS, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, FODMAP, microbiota
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).
Interventions
OTHERTraditional Finnish rye bread
OTHERLow FODMAP rye bread
Sponsors
Oy Karl Fazer Ab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change is IBS symptoms by using IBS-SSS questionaire | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Finland
Outcome results
None listed