Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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).

Official Title
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Effects of Traditional and Low-FODMAP Rye Bread in Irritable Bowel Syndrome.

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Other: Traditional Finnish rye bread
* Other: Low FODMAP rye bread


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional rye bread<br>As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily | Other: Traditional Finnish rye bread<br> <br> |
| Experimental: Low-FODMAP rye bread<br>As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily | Other: Low FODMAP rye bread<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is IBS symptoms by using IBS-SSS questionaire |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, FODMAP, microbiota