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NCT02572908 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

— Wheat-IBS  

Official title:
Effects of Wheat Breads on Symptoms of IBS, a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02572908
Other study ID # Wheat-IBS
Secondary ID
Status Completed
Phase N/A
First received October 5, 2015
Last updated August 4, 2016
Start date August 2015
Est. completion date March 2016

Study information
Verified date August 2016
Source Oy Karl Fazer Ab
Contact n/a
Is FDA regulated No
Health authority Finland: 'Ethics committee'
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- IBS & subjective sensitivity to wheat

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Sourdough wheat bread

• Regular yeast baked toast bread

• Gluten-free diet
Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains

Locations
Country Name City State
Finland Aava Medical Centre Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Oy Karl Fazer Ab

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 7 days No
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