- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02161120
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
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Helsinki, Finland, 00100
- Aava Medical Centre
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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
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Experimental: Low-FODMAP rye bread
As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily
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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
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
IBS quality of life by using IBS QoL questionnaire
Time Frame: 4 weeks
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4 weeks
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Changes in specific IBS symptoms measured by 100 mm VAS scale
Time Frame: 4 weeks
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4 weeks
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Changes is intestinal microbiota evaluated by fecal samples
Time Frame: 4 weeks
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4 weeks
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Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast
Time Frame: 4 weeks
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
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.
Clinical Trials on Irritable Bowel Syndrome
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
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Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
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Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
-
University of California, Los AngelesCompletedIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Mixed Bowel HabitsUnited States
-
University of ViennaCompleted
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Thomayer University HospitalCharles University, Czech RepublicActive, not recruitingIrritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome MixedCzechia
-
Shahid Beheshti University of Medical SciencesCompletedIrritable Bowel DiseaseIran, Islamic Republic of
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Universidad Autonoma de ChihuahuaNot yet recruitingIrritable Bowel Syndrome | Constipation-predominant Irritable Bowel Syndrome | Diarrhea- Irritable Bowel Syndrome
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Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
Clinical Trials on Traditional Finnish rye bread
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University of Eastern FinlandVTT Technical Research Centre of FinlandCompletedGlucose Metabolism Disorders | Inflammation | Intestinal Disorder
-
University of Illinois at Urbana-ChampaignRecruitingCardiovascular Diseases | Dysbiosis | Gastrointestinal Dysfunction | Nutritional and Metabolic DiseasesUnited States
-
Swedish University of Agricultural SciencesUppsala UniversityCompletedAppetite RegulationSweden
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Swedish University of Agricultural SciencesGood Food Practice, Sweden; Lantmännen R&DCompleted
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Chalmers University of TechnologySahlgrenska University Hospital, SwedenCompletedAnaemia | Iron Bioavailability
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Swedish University of Agricultural SciencesGood Food Practice, Sweden; Lantmannen Research and DevelopmentUnknown
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Swedish University of Agricultural SciencesUppsala UniversityCompleted
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University of HelsinkiFazer GroupUnknownBlood Glucose Concentration
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Marjukka KolehmainenWageningen University; VTT Technical Research Centre, FinlandCompletedObesity | Metabolic Syndrome | Impaired Glucose Tolerance | Impaired Fasting GlucoseFinland
-
Swedish University of Agricultural SciencesUppsala UniversityCompletedAppetite RegulationSweden