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Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT02161120
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Traditional Finnish rye bread Other: Low FODMAP rye bread Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Traditional and Low-FODMAP Rye Bread in Irritable Bowel Syndrome.
Study Start Date : April 2014
Actual Primary Completion Date : February 2015

Arm Intervention/treatment
Active Comparator: Traditional rye bread
As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily
Other: Traditional Finnish rye bread
Experimental: Low-FODMAP rye bread
As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily
Other: Low FODMAP rye bread



Primary Outcome Measures :
  1. Change is IBS symptoms by using IBS-SSS questionaire [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. IBS quality of life by using IBS QoL questionnaire [ Time Frame: 4 weeks ]
  2. Changes in specific IBS symptoms measured by 100 mm VAS scale [ Time Frame: 4 weeks ]
  3. Changes is intestinal microbiota evaluated by fecal samples [ Time Frame: 4 weeks ]
  4. Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161120


Locations
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Finland
Aava Medical Centre
Helsinki, Finland, 00100
Sponsors and Collaborators
Oy Karl Fazer Ab

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oy Karl Fazer Ab
ClinicalTrials.gov Identifier: NCT02161120    
Other Study ID Numbers: BSTN-2014-rye
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: March 31, 2015
Last Verified: March 2015
Keywords provided by Oy Karl Fazer Ab:
IBS, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, FODMAP, microbiota
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases