Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

March 28, 2015 updated by: Oy Karl Fazer Ab

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00100
        • Aava Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change is IBS symptoms by using IBS-SSS questionaire
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oy Karl Fazer Ab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 31, 2015

Last Update Submitted That Met QC Criteria

March 28, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSTN-2014-rye

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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