Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

Oy Karl Fazer Ab87 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

Traditional Finnish rye breadOTHER

Low FODMAP rye breadOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Aava Medical Centre

Helsinki, Helsinki, Finland

Outcomes

Primary Outcomes

Change is IBS symptoms by using IBS-SSS questionaire

Time frame: 4 weeks

Secondary Outcomes

IBS quality of life by using IBS QoL questionnaire

Time frame: 4 weeks

Changes in specific IBS symptoms measured by 100 mm VAS scale

Time frame: 4 weeks

Changes is intestinal microbiota evaluated by fecal samples

Time frame: 4 weeks

Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast

Time frame: 4 weeks

Data from ClinicalTrials.gov

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