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
• 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
• 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. 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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

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