Irritable Bowel SyndromeNCT02161120
Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome
A study testing Traditional Finnish rye bread and Low FODMAP rye bread in people with Irritable Bowel Syndrome, run by Oy Karl Fazer Ab at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Traditional Finnish rye bread and Low FODMAP rye bread
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2014to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Traditional Finnish rye bread, Low FODMAP rye bread
- Keywords
- IBS, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, FODMAP, microbiota
- Medical subject headings
- Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Finnish rye breadOther
Low FODMAP rye breadOther
| Study group | Role | What they receive |
|---|---|---|
| Traditional rye bread | Active comparator | As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily Receives: Other: Traditional Finnish rye bread |
| Low-FODMAP rye bread | Experimental | As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily Receives: Other: Low FODMAP rye bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is IBS symptoms by using IBS-SSS questionaire
Measured: 4 weeks
Secondary outcomes (4)
IBS quality of life by using IBS QoL questionnaire
Measured: 4 weeks
Changes in specific IBS symptoms measured by 100 mm VAS scale
Measured: 4 weeks
Changes is intestinal microbiota evaluated by fecal samples
Measured: 4 weeks
Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oy Karl Fazer Ab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161120
- Sponsor's protocol ID
- BSTN-2014-rye
- Status last verified
- Mar 2015
- First submitted
- 10 Jun 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Laatikainen R, Jalanka J, Loponen J, Hongisto SM, Hillila M, Koskenpato J, Korpela R, Salonen A. Randomised clinical trial: effect of low-FODMAP rye bread versus regular rye bread on the intestinal microbiota of irritable bowel syndrome patients: association with individual symptom variation. BMC Nutr. 2019 Mar 6;5:12. doi: 10.1186/s40795-019-0278-7. eCollection 2019.
PubMed 32153925
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Traditional and Low-FODMAP Rye Bread in Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT02161120
- Acronym / sponsor ID
- BSTN-2014-rye
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, FODMAP, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Oy Karl Fazer AbIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional rye bread | Active comparator | Other: Traditional Finnish rye breadAs part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily |
| Low-FODMAP rye bread | Experimental | Other: Low FODMAP rye breadAs part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- IBS-C (constipation dominant)
- Celiac disease
- IBD
- Major gastrointestinal operations like bowel gastric resection
- Non-treated hypo- or hyperthyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Finnish rye bread | Other | Traditional rye bread |
| Low FODMAP rye bread | Other | Low-FODMAP rye bread |
Primary outcome
Change is IBS symptoms by using IBS-SSS questionaire
Time frame: 4 weeks
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Derived from this study: PubMed 32153925Laatikainen R, Jalanka J, Loponen J, Hongisto SM, Hillila M, Koskenpato J, Korpela R, Salonen A. Randomised clinical trial: effect of low-FODMAP rye bread versus regular rye bread on the intestinal microbiota of irritable bowel syndrome patients: association with individual symptom variation. BMC Nutr. 2019 Mar 6;5:12. doi: 10.1186/s40795-019-0278-7. eCollection 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Finnish rye bread and Low FODMAP rye bread in people with Irritable Bowel Syndrome, run by Oy Karl Fazer Ab at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change is IBS symptoms by using IBS-SSS questionaire (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.