Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Traditional Finnish rye bread; Other: Low FODMAP rye bread

• 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

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Primary Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-28
• Last Update Posted: 2015-03-31

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

Arm && Interventions

Group	Intervention	Description
Traditional rye bread	Traditional Finnish rye bread	As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily
Low-FODMAP rye bread	Low FODMAP rye bread	As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily

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