Effects of Wheat Breads on Symptoms of IBS, a Pilot Study (Wheat-IBS)
August 4, 2016 updated by: Oy Karl Fazer Ab
This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
26
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
-
-
-
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 & subjective sensitivity to wheat
Exclusion Criteria:
- celiac disease, pregnancy, lactation, IBD, major GI operations
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: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Fermented wheat bread for 7 days
Long sourdough fermentation
|
Gluten-free diet excluding even oats and buckwheat.
Rice, quinoa, corn and potato allowed as grains/pseudo-grains
|
|
Placebo Comparator: Yeast baked wheat bread for 7 days
Regular toast bread
|
Gluten-free diet excluding even oats and buckwheat.
Rice, quinoa, corn and potato allowed as grains/pseudo-grains
|
|
Other: Run-in
Gluten-free diet for 7 days before entering either bread period
|
Gluten-free diet excluding even oats and buckwheat.
Rice, quinoa, corn and potato allowed as grains/pseudo-grains
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
October 5, 2015
First Submitted That Met QC Criteria
October 8, 2015
First Posted (Estimate)
October 9, 2015
Study Record Updates
Last Update Posted (Estimate)
August 5, 2016
Last Update Submitted That Met QC Criteria
August 4, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wheat-IBS
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.