NCT02161120

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Last Updated

March 31, 2015

Status Verified

March 1, 2015

Enrollment Period

10 months

First QC Date

June 10, 2014

Last Update Submit

March 28, 2015

Conditions

Irritable Bowel Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Change is IBS symptoms by using IBS-SSS questionaire

    4 weeks

Secondary Outcomes (4)

  • IBS quality of life by using IBS QoL questionnaire

    4 weeks

  • Changes in specific IBS symptoms measured by 100 mm VAS scale

    4 weeks

  • Changes is intestinal microbiota evaluated by fecal samples

    4 weeks

  • Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast

    4 weeks

Study Arms (2)

Traditional rye bread

ACTIVE COMPARATOR

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

Other: Traditional Finnish rye bread

Low-FODMAP rye bread

EXPERIMENTAL

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

Other: Low FODMAP rye bread

Interventions

Traditional Finnish rye breadOTHER
Traditional rye bread
Low FODMAP rye breadOTHER
Low-FODMAP rye bread

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aava Medical Centre

Helsinki, Helsinki, 00100, Finland

Location

Related Publications (1)

  • 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.

    PMID: 32153925DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeIchthyosis Bullosa of SiemensGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesDigestive System DiseasesIchthyosisSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornInfant, Newborn, DiseasesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 11, 2014

Study Start

April 1, 2014

Primary Completion

February 1, 2015

Last Updated

March 31, 2015

Record last verified: 2015-03

Locations

FI(1)