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NCT02161120 Clinical Trial

Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02161120
Other study ID # BSTN-2014-rye
Secondary ID
Status Completed
Phase N/A
First received June 10, 2014
Last updated March 28, 2015
Start date April 2014

Study information
Verified date March 2015
Source Oy Karl Fazer Ab
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 87
Est. completion date
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Traditional Finnish rye bread

• Low FODMAP rye bread

Locations
Country Name City State
Finland Aava Medical Centre Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Oy Karl Fazer Ab

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change is IBS symptoms by using IBS-SSS questionaire 4 weeks
Secondary IBS quality of life by using IBS QoL questionnaire 4 weeks
Secondary Changes in specific IBS symptoms measured by 100 mm VAS scale 4 weeks
Secondary Changes is intestinal microbiota evaluated by fecal samples 4 weeks
Secondary Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast 4 weeks
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