Clinical Trial: Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effects of Traditional and Low-FODMAP Rye Bread in Irritable Bowel Syndrome.
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 Summary:
Sponsor: Oy Karl Fazer Ab
Current Primary Outcome: Change is IBS symptoms by using IBS-SSS questionaire [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Oy Karl Fazer Ab
Dates:
Date Received: June 10, 2014
Date Started: April 2014
Date Completion:
Last Updated: March 28, 2015
Last Verified: March 2015
