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Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

NCT ID: NCT02161120

Last Updated: 2015-03-31

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

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Brief Summary

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The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-, Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than commonly available traditional rye bread higher in FODMAP carbohydrates. The study also aims to investigate patients' compliance to rye bread regimen, potential changes is gut microbiota and hydrogen production during the test periods (a marker of large bowel fermentation of poorly absorbed carbohydrates).

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Keywords

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IBS, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, FODMAP, microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Traditional rye bread

As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily

Group Type ACTIVE_COMPARATOR

Traditional Finnish rye bread

Intervention Type OTHER

Low-FODMAP rye bread

As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily

Group Type EXPERIMENTAL

Low FODMAP rye bread

Intervention Type OTHER

Interventions

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Traditional Finnish rye bread

Intervention Type OTHER

Low FODMAP rye bread

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* IBS according to Rome III criteria. Accepted sub-types include IBS-M, IBS-D and IBS-U
* Age 18-65 years
* Willing to use rye bread daily during the study periods

Exclusion Criteria

* IBS-C (constipation dominant)
* Celiac disease
* IBD
* Major gastrointestinal operations like bowel gastric resection
* Non-treated hypo- or hyperthyroidism
* Alcoholism, severe depression, dementia, cancer or other diseases likely to severly impair the participants ability to conclude the protocol
* Regular (almost daily) use of NSAIDs, antibiotics or lactulose
* Linaclotide and other prescription medicines targeted specifically to IBS
* Pregnancy and lactation
* Follows currently strict low-FODMAP diet
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

References

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Laatikainen R, Jalanka J, Loponen J, Hongisto SM, Hillila M, Koskenpato J, Korpela R, Salonen A. Randomised clinical trial: effect of low-FODMAP rye bread versus regular rye bread on the intestinal microbiota of irritable bowel syndrome patients: association with individual symptom variation. BMC Nutr. 2019 Mar 6;5:12. doi: 10.1186/s40795-019-0278-7. eCollection 2019.

Reference Type DERIVED
PMID: 32153925 (View on PubMed)

Other Identifiers

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BSTN-2014-rye

Identifier Type: -

Identifier Source: org_study_id