Effects of Wheat Breads on Symptoms of IBS, a Pilot Study

This is randomized pilot study comparing tolerability of yeast-baked wheat bread and sourdough wheat bread in irritable bowel syndrome.

Completed

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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 Wheat Sensitivity

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 & subjective sensitivity to wheat

Exclusion criteria

celiac disease, pregnancy, lactation, IBD, major GI operations

Treatment and study plan

Sourdough wheat bread

Other

Regular yeast baked toast bread

Other

Gluten-free diet

Other

Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains

Primary outcomes

Subjective symptoms using visual analog scale (VAS) daily

Time frame: 7 days

Self-reports of bloating, dyspepsia, constipation, diarrhoea, abdominal pain, borborygmi, flatulence, heart burn, urgency to defecate, incomplete feeling of defecation, abdominal cramps, tiredness, skin rash, mood, nausea, joint pain, ability to concentrate and loss of appetite on VAS 0-100. Participants fill in VAS questionnaires at the end of each day

Sponsors and collaborators

Lead sponsor

Oy Karl Fazer Ab

Industry

Registry information

Acronym: Wheat-IBS

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 9, 2015
Registry last updated: Aug 5, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed