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Completed

NCT Number: NCT02161120

Effect of Two Different Rye Bread Types in Irritable Bowel Syndrome

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).

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Ichthyosis Ichthyosis Bullosa of Siemens Infant, Newborn, Diseases Intestinal Diseases Keratosis Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aava Medical Centre

Helsinki, 00100, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional Finnish rye bread

Other

Low FODMAP rye bread

Other

Primary outcomes

  1. Change is IBS symptoms by using IBS-SSS questionaire

    Time frame: 4 weeks

Secondary outcomes

  1. IBS quality of life by using IBS QoL questionnaire

    Time frame: 4 weeks

  2. Changes in specific IBS symptoms measured by 100 mm VAS scale

    Time frame: 4 weeks

  3. Changes is intestinal microbiota evaluated by fecal samples

    Time frame: 4 weeks

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

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Oy Karl Fazer Ab

Industry

Registry information

Official study title

Effects of Traditional and Low-FODMAP Rye Bread in Irritable Bowel Syndrome.

Important dates

Study start
2014
Primary completion
2015
First posted
Jun 11, 2014
Registry last updated
Mar 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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