Effects of Wheat Breads on Symptoms of IBS, a Pilot Study

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome; Wheat Sensitivity
• Interventions: Other: Sourdough wheat bread; Other: Regular yeast baked toast bread; Other: Gluten-free diet

• Registration Number: NCT02572908
• Lead Sponsor: Oy Karl Fazer Ab

Brief Summary

This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-10-05
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-04
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• IBS & subjective sensitivity to wheat

Exclusion Criteria

• celiac disease, pregnancy, lactation, IBD, major GI operations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yeast baked wheat bread for 7 days	Gluten-free diet	Regular toast bread
Fermented wheat bread for 7 days	Sourdough wheat bread	Long sourdough fermentation
Fermented wheat bread for 7 days	Gluten-free diet	Long sourdough fermentation
Run-in	Gluten-free diet	Gluten-free diet for 7 days before entering either bread period
Yeast baked wheat bread for 7 days	Regular yeast baked toast bread	Regular toast bread

Primary Outcome Measures

Name	Time	Method
Subjective symptoms using visual analog scale (VAS) daily	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

Trial Locations

Locations (1)

Aava Medical Centre; 🇫🇮 Helsinki, Finland