Trial document





This trial has been registered retrospectively.
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  DRKS00013534

Trial Description

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Title

Compatibility of a low-FODMAP wheat bread compared to a regular wheat bread in persons suffering from irritable bowel syndrome: a randomized, controlled, double-blind crossover trial.

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Trial Acronym

[---]*

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URL of the Trial

http://www.uksh.de/Ernaehrungsmedizin_Luebeck/Wissenschaft/Klinische+Studien/Brot_Studie-p-44.html

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Brief Summary in Lay Language

The content of rapidly fermentable short-chain sugars (fermentable oligo-, di- and monosaccharides and polyols (FODMAP)) in wheat bread is comparatively low. Nevertheless due to the high consumption of wheat worldwide, this content contributes considerably to the daily FODMAP-intake. A low-FODMAP diet, which is known as an effective therapy for patients with irritable bowel syndrome (IBS), is associated with the avoidance of wheat bread. This study trial examines the tolerability of low-FODMAP wheat bread in comparison to regular wheat bread in patients with IBS. Also included are patients who report sensitivity to wheat or gluten in addition to the IBS-symptoms. Excluded are patients with gluten intolerance (celiac disease) or wheat allergy. The study duration is four weeks. A gluten free diet serves as a background diet. Each participant consumes both breads, one in the second and the other in the fourth week of the study. It is not known which variety is served when. Symptom questionnaires are used to measure tolerability. In addition, stool sample analyzes are intended to detect possible changes in the distribution of intestinal bacterial strains.

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Brief Summary in Scientific Language

The content of fermentable oligo-, di- and monosaccharides and polyols (FODMAP) in wheat bread is comparatively low. Nevertheless due to the high consumption of wheat worldwide, this content contributes considerably to the daily FODMAP-intake. A low-FODMAP diet, which is known as an effective therapy for patients with irritable bowel syndrom (IBS), is associated with the avoidance of wheat bread. The aim of this study is to evaluate the tolerability of low-FODMAP wheat bread in individuals with IBS compared to regular wheat bread. Therefore the primary hypothesis of the study is that the compatibility of low-FODMAP wheat bread differs from regular wheat bread in individuals with IBS. The study was conducted as a randomised double blind controlled crossover study (n = 98). A gluten free diet was served as a background diet. IBS-severity (primary outcome) was measured with the Severity Scoring System (IBS-SSS) and visual analogue scale (VAS). The VAS was also used for the assessment of individual symptoms (secondary outcome). The duration of the study was four weeks, starting with a one-week gluten-free run-in period, a first one-week bread phase, a one-week wash-out phase and the second one-week bread phase.

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Organizational Data

  •   DRKS00013534
  •   2017/12/15
  •   [---]*
  •   no
  •   Approved
  •   17-021, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   K58 -  Irritable bowel syndrome
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Interventions/Observational Groups

  •   one-week gluten-free run-in period, first one-week bread phase (low-FODMAP wheatbread, 130 g daily), one-week wash-out Phase, second one-week bread phase (regular wheatbread, 130 g daily)
  •   one-week gluten-free run-in period, first one-week bread phase (regular wheatbread, 130 g daily), one-week wash-out Phase, second one-week bread phase (low-FODMAP wheatbread, 130 g daily)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Control group receives no treatment
  •   Other
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

At the end of each bread phase, changes in the irritable bowel syndrome (IBS)-severity during the FODMAP-reduced wheat phase compared to the regular wheat phase are determined using the IBS-Severity Scoring System (IBS-SSS) via a visual analogue scale (VAS).

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Secondary Outcome

At the beginning and at the end of the 1st, 2nd, 3rd and 4th week, changes in severity of intestinal and extraintestinal symptoms are analyzed individually and overall using VAS. At the same time points, quality of life using the EQ-5D-5L questionnaire are determined as well as the microbiome by stool sample analysis.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/04/05
  •   98
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Sufficient knowledge of the German language to understand the study documents and the information materials for implementation of the gluten-free diet
• Irritable bowel syndrome diagnosis according to the Rome-III-criteria or RDS-like symptoms excluding other intestinal diseases

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Exclusion Criteria

• Pregnancy, person in lactation
• Diagnosis of other functional bowel diseases such as celiac disease, wheat allergy or inflammatory bowel disease
• Alcohol addiction
• Intake of medicines that affect the gastrointestinal tract, e.g. Antidiarrheals and proton pump inhibitors
• Intake of antibiotics and/or probiotics during the last three months

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Ernährungsmedizin
    • Mr.  Prof. Dr. med.  Christian  Sina 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Institut für Ernährungsmedizin
    • Mr.  Prof. Dr. med.  Christian  Sina 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Institut für Ernährungsmedizin
    • Ms.  Katharina  Schlumm 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • GoodMills Innovation GmbH
    • Trettaustraße 32-34
    • 21107  Hamburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/08/07
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.