Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

Oy Karl Fazer Ab

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: Low FODMAP rye bread; Other: Traditional Finnish rye bread

Study type: Interventional

Funder types: Industry

Identifiers

NCT02161120

BSTN-2014-rye

Details and patient eligibility

About

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).

Enrollment: 87 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups

Traditional rye bread

Active Comparator group

Description:

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

Treatment:

Other: Traditional Finnish rye bread

Low-FODMAP rye bread

Experimental group

Description:

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

Treatment:

Other: Low FODMAP rye bread