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Clinical Trials/NCT02572908
NCT02572908CompletedNot Applicable

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

Oy Karl Fazer Ab2 sites in 1 country26 target enrollmentStarted: August 2015Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
2
Primary Endpoint
Subjective symptoms using visual analog scale (VAS) daily
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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Effects of Wheat Breads on Symptoms of... | Clinical Trial