Irritable Bowel SyndromeWheat-IBSNCT02572908
Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
A study testing Sourdough wheat bread, Regular yeast baked toast bread and Gluten-free diet in people with Irritable Bowel Syndrome and Wheat Sensitivity, run by Oy Karl Fazer Ab at 1 site in Finland.
Trial summary
This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome, Wheat Sensitivity
- What is being tested?
- Sourdough wheat bread, Regular yeast baked toast bread and Gluten-free diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2015to Mar 2016
- 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 \& subjective sensitivity to wheat
Who cannot join
- celiac disease, pregnancy, lactation, IBD, major GI operations
Trial locations and contacts
1 site in 1 country.
About this study
This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.
- Conditions
- Irritable Bowel Syndrome, Wheat Sensitivity
- Being tested
- Sourdough wheat bread, Regular yeast baked toast bread, Gluten-free diet
- Keywords
- wheat, IBS, gluten, ATI
- Medical subject headings
- Irritable Bowel Syndrome, Ichthyosis Bullosa of Siemens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sourdough wheat breadOther
Regular yeast baked toast breadOther
Gluten-free dietOther
Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains
| Study group | Role | What they receive |
|---|---|---|
| Fermented wheat bread for 7 days | Active comparator | Long sourdough fermentation Receives: Other: Sourdough wheat bread; Other: Gluten-free diet |
| Yeast baked wheat bread for 7 days | Placebo comparator | Regular toast bread Receives: Other: Regular yeast baked toast bread; Other: Gluten-free diet |
| Run-in | Other | Gluten-free diet for 7 days before entering either bread period Receives: Other: Gluten-free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective symptoms using visual analog scale (VAS) daily
Self-reports of bloating, dyspepsia, constipation, diarrhoea, abdominal pain, borborygmi, flatulence, heart burn, urgency to defecate, incomplete feeling of defecation, abdominal cramps, tiredness, skin rash, mood, nausea, joint pain, ability to concentrate and loss of appetite on VAS 0-100. Participants fill in VAS questionnaires at the end of each day
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
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
- NCT02572908
- Sponsor's protocol ID
- Wheat-IBS
- Acronym
- Wheat-IBS
- Status last verified
- Aug 2016
- First submitted
- 5 Oct 2015
- Last updated
- 5 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
- ClinicalTrials.gov ID
- NCT02572908
- Acronym / sponsor ID
- Wheat-IBS / Wheat-IBS
- Conditions
- Irritable Bowel Syndrome, Wheat Sensitivity
- Keywords
- wheat, IBS, gluten, ATI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Oy Karl Fazer AbIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Oct 2015 (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.
This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fermented wheat bread for 7 days | Active comparator | Other: Sourdough wheat bread, Other: Gluten-free dietLong sourdough fermentation |
| Yeast baked wheat bread for 7 days | Placebo comparator | Other: Regular yeast baked toast bread, Other: Gluten-free dietRegular toast bread |
| Run-in | Other | Other: Gluten-free dietGluten-free diet for 7 days before entering either bread period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- IBS \& subjective sensitivity to wheat
Key exclusion criteria (1 listed)
- celiac disease, pregnancy, lactation, IBD, major GI operations
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 |
|---|---|---|
| Sourdough wheat bread | Other | Fermented wheat bread for 7 days |
| Regular yeast baked toast bread | Other | Yeast baked wheat bread for 7 days |
| Gluten-free dietGluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains | Other | Fermented wheat bread for 7 days, Run-in, Yeast baked wheat bread for 7 days |
Primary outcome
Subjective symptoms using visual analog scale (VAS) daily
Time frame: 7 days
Self-reports of bloating, dyspepsia, constipation, diarrhoea, abdominal pain, borborygmi, flatulence, heart burn, urgency to defecate, incomplete feeling of defecation, abdominal cramps, tiredness, skin rash, mood, nausea, joint pain, ability to concentrate and loss of appetite on VAS 0-100. Participants fill in VAS questionnaires at the end of each day
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 5 Aug 2016.
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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 Sourdough wheat bread, Regular yeast baked toast bread and Gluten-free diet in people with Irritable Bowel Syndrome and Wheat Sensitivity, 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 1 inclusion and 1 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 5 Aug 2016. 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. Some participants in this study may receive a placebo. 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?
Subjective symptoms using visual analog scale (VAS) daily (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2016.