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Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Traditional Finnish rye bread
Low FODMAP rye bread
Sponsored by
Oy Karl Fazer Ab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, FODMAP, microbiota

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aava Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional rye bread

Low-FODMAP rye bread

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change is IBS symptoms by using IBS-SSS questionaire

Secondary Outcome Measures

IBS quality of life by using IBS QoL questionnaire
Changes in specific IBS symptoms measured by 100 mm VAS scale
Changes is intestinal microbiota evaluated by fecal samples
Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast

Full Information

First Posted
June 10, 2014
Last Updated
March 28, 2015
Sponsor
Oy Karl Fazer Ab
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1. Study Identification

Unique Protocol Identification Number
NCT02161120
Brief Title
Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome
Official Title
Effects of Traditional and Low-FODMAP Rye Bread in Irritable Bowel Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oy Karl Fazer Ab

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
IBS, irritable bowel syndrome, functional gastrointestinal disorder, diet, bread, rye, FODMAP, microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional rye bread
Arm Type
Active Comparator
Arm Description
As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily
Arm Title
Low-FODMAP rye bread
Arm Type
Experimental
Arm Description
As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily
Intervention Type
Other
Intervention Name(s)
Traditional Finnish rye bread
Intervention Type
Other
Intervention Name(s)
Low FODMAP rye bread
Primary Outcome Measure Information:
Title
Change is IBS symptoms by using IBS-SSS questionaire
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
IBS quality of life by using IBS QoL questionnaire
Time Frame
4 weeks
Title
Changes in specific IBS symptoms measured by 100 mm VAS scale
Time Frame
4 weeks
Title
Changes is intestinal microbiota evaluated by fecal samples
Time Frame
4 weeks
Title
Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Aava Medical Centre
City
Helsinki
ZIP/Postal Code
00100
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
32153925
Citation
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.
Results Reference
derived

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Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

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