Effects of Wheat Breads on Symptoms of IBS, a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oy Karl Fazer Ab
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Subjective symptoms using visual analog scale (VAS) daily
Study Overview
Brief Summary
This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •IBS & subjective sensitivity to wheat
Exclusion Criteria
- •celiac disease, pregnancy, lactation, IBD, major GI operations
Arms & Interventions
Fermented wheat bread for 7 days
Long sourdough fermentation
Intervention: Sourdough wheat bread (Other)
Fermented wheat bread for 7 days
Long sourdough fermentation
Intervention: Gluten-free diet (Other)
Yeast baked wheat bread for 7 days
Regular toast bread
Intervention: Regular yeast baked toast bread (Other)
Yeast baked wheat bread for 7 days
Regular toast bread
Intervention: Gluten-free diet (Other)
Run-in
Gluten-free diet for 7 days before entering either bread period
Intervention: Gluten-free diet (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported