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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02572908
Acronym
Wheat-IBS
Enrollment
26
Registered
2015-10-09
Start date
2015-08-31
Completion date
2016-03-31
Last updated
2016-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome, Wheat Sensitivity

Keywords

wheat, IBS, gluten, ATI

Brief summary

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

Interventions

OTHERSourdough wheat bread
OTHERRegular yeast baked toast bread
OTHERGluten-free diet

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

Sponsors

Oy Karl Fazer Ab
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* IBS & subjective sensitivity to wheat

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective symptoms using visual analog scale (VAS) daily7 daysSelf-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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026