Completed

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

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What is being tested

Traditional Finnish rye bread

+ Low FODMAP rye bread

Other
Who is being recruted

Congenital Abnormalities+14

+ Colonic Diseases

+ Colonic Diseases, Functional

From 18 to 65 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2014
See protocol details

Summary

Principal SponsorOy Karl Fazer Ab
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2014

Actual date on which the first participant was enrolled.

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).

Official TitleEffects of Traditional and Low-FODMAP Rye Bread in Irritable Bowel Syndrome.
NCT02161120
Principal SponsorOy Karl Fazer Ab
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

87 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesColonic DiseasesColonic Diseases, FunctionalDigestive System DiseasesGastrointestinal DiseasesIchthyosisInfant, Newborn, DiseasesIntestinal DiseasesKeratosisCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin AbnormalitiesSkin DiseasesSkin Diseases, GeneticSkin and Connective Tissue DiseasesGenetic Diseases, InbornIrritable Bowel SyndromeIchthyosis Bullosa of Siemens

Criteria

3 inclusion criteria required to participate
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
10 exclusion criteria prevent from participating
IBD
IBS-C (constipation dominant)
Celiac disease
Major gastrointestinal operations like bowel gastric resection
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily

Group II

Experimental
As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Aava Medical Centre

Helsinki, FinlandOpen Aava Medical Centre in Google Maps
CompletedOne Study Center