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

NCT ID: NCT02572908

Last Updated: 2016-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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Conditions

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Irritable Bowel Syndrome Wheat Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fermented wheat bread for 7 days

Long sourdough fermentation

Group Type ACTIVE_COMPARATOR

Sourdough wheat bread

Intervention Type OTHER

Gluten-free diet

Intervention Type OTHER

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

Yeast baked wheat bread for 7 days

Regular toast bread

Group Type PLACEBO_COMPARATOR

Regular yeast baked toast bread

Intervention Type OTHER

Gluten-free diet

Intervention Type OTHER

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

Run-in

Gluten-free diet for 7 days before entering either bread period

Group Type OTHER

Gluten-free diet

Intervention Type OTHER

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

Interventions

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Sourdough wheat bread

Intervention Type OTHER

Regular yeast baked toast bread

Intervention Type OTHER

Gluten-free diet

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* IBS \& subjective sensitivity to wheat

Exclusion Criteria

* celiac disease, pregnancy, lactation, IBD, major GI operations
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oy Karl Fazer Ab

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aava Medical Centre

Helsinki, Helsinki, Finland

Site Status

Countries

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Finland

Other Identifiers

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Wheat-IBS

Identifier Type: -

Identifier Source: org_study_id

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