Back to resultsEffects of Wheat Breads on Symptoms of IBS, a Pilot Study (Wheat-IBS)
Primary Purpose
Irritable Bowel Syndrome, Wheat Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Sourdough wheat bread
Regular yeast baked toast bread
Gluten-free diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring wheat, IBS, gluten, ATI
Eligibility Criteria
Inclusion Criteria:
- IBS & subjective sensitivity to wheat
Exclusion Criteria:
- celiac disease, pregnancy, lactation, IBD, major GI operations
Sites / Locations
- Aava Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Other
Arm Label
Fermented wheat bread for 7 days
Yeast baked wheat bread for 7 days
Run-in
Arm Description
Long sourdough fermentation
Regular toast bread
Gluten-free diet for 7 days before entering either bread period
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02572908
Brief Title
Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
Acronym
Wheat-IBS
Official Title
Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oy Karl Fazer Ab
4. Oversight
5. Study Description
Brief Summary
This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Wheat Sensitivity
Keywords
wheat, IBS, gluten, ATI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fermented wheat bread for 7 days
Arm Type
Active Comparator
Arm Description
Long sourdough fermentation
Arm Title
Yeast baked wheat bread for 7 days
Arm Type
Placebo Comparator
Arm Description
Regular toast bread
Arm Title
Run-in
Arm Type
Other
Arm Description
Gluten-free diet for 7 days before entering either bread period
Intervention Type
Other
Intervention Name(s)
Sourdough wheat bread
Intervention Type
Other
Intervention Name(s)
Regular yeast baked toast bread
Intervention Type
Other
Intervention Name(s)
Gluten-free diet
Intervention Description
Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains
Primary Outcome Measure Information:
Title
Subjective symptoms using visual analog scale (VAS) daily
Description
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
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
IBS & subjective sensitivity to wheat
Exclusion Criteria:
celiac disease, pregnancy, lactation, IBD, major GI operations
Facility Information:
Facility Name
Aava Medical Centre
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
12. IPD Sharing Statement
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