Trial document




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  DRKS00010123

Trial Description

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Title

Prospective, double-blind diagnostic study of confocal laser endomicroscopy (CLE) for wheat sensitivity (WS) in patients with irritable bowel syndrome

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Trial Acronym

LEWIS

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URL of the Trial

http://reizdarmstudie.charite.de

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Brief Summary in Lay Language

30%-50% of patients with the irritable bowel syndrome (IBS) could suffer from wheat sensitivity.
Our study tests a new technique to predict which IBS patients are wheat sensitive. We examine by confocal laser endomicroscopy small intestine reactions to wheat. The test results will be compared with the clinical response of the patients to a gluten-free diet.

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Brief Summary in Scientific Language

The irritable bowel syndrome (IBS) affects about 12% of the population in Northern Europe. Up to one third of patients fulfilling the Rome III criteria of IBS may be wheat-sensitive and respond to a gluten-free diet (GFD) although they do not have celiac disease. However, a diagnostic test for wheat sensitivity (WS) is missing.
In this diagnostic accuracy study the predictive ability of confocal laser endomicroscopy (CLE) to discriminate between patients with and without WS will be evaluated. Non-celiac patients fulfilling the Rome III criteria for IBS will be tested by CLE for wheat-induced changes (index test). IBS patients responding to GFD will be classified as having WS (reference test).
Our study aims to establish CLE as a reliable diagnostic tool to identify WS in IBS patients who would profit long-term from GFD as a causative treatment.

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Organizational Data

  •   DRKS00010123
  •   2016/03/22
  •   [---]*
  •   yes
  •   Approved
  •   EA4/023/16, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K58.0 -  Irritable bowel syndrome with diarrhoea
  •   K58.9 -  Irritable bowel syndrome without diarrhoea
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Interventions/Observational Groups

  •   Patients with the irritable bowel syndrome fulfilling the Rome III criteria will be examined by confocal laser endomicroscopy for mucosal reactions to duodenal instillation of suspensions of wheat, soy, yeast, and cow's milk. Blinded to the results patients will try a gluten-free diet for two months and responders will be classified as wheat sensitive. Following unblinding patients will receive another dietary counselling and symptoms will be examined after 6 and 12 months.
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Other
  •   Diagnostic
  •   Other
  •   III
  •   N/A
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Primary Outcome

Index test: IBS patients will be tested by CLE (confocal laser endomicroscopy) for wheat-induced changes.
Reference test: IBS patients responding to gluten-free diet will be classified as having WS. Patients will be classified as responders if they report on weekly interviews complete or considerable relief of IBS symptoms on at least 50% of weeks over a 2-month period of gluten-free diet, and an abdominal pain score assessed by symptom diary improved by at least 30%.

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Secondary Outcome

Change in IBS symptoms (IBS-SSS) and quality of life (IBS-QOL, EQ-5D), proportion of responders at follow-up after 6 and 12 months, proportions of early and sustained responders

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2016/05/24
  •   130
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

fulfillment of Rome III criteria for IBS
daily symptoms worsening after meals
score ≥ 175 of the IBS-SSS questionnaire
normal gastroscopy including histology
normal colonoscopy within the last five years
able and willing to follow a GFD
capable of understanding and signing an informed consent form

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Exclusion Criteria

chronic gastrointestinal disease;
elevated anti-TTG IgA (reference < 10 mU/l);
elevated wheat-specific IgE;
abnormal lactose hydrogen breath test;
beta-blocker treatment;
antidepressant drug treatment;
involuntary weight loss of more than 10% of body; weight within the last 6 months;
fever (body temperature >38.5°C);
CRP >0.5 mg/l;
WBC ≥10.5/nl;
chronic heart failure (NYHA III and IV);
pregnancy;
renal failure with increased creatinine;
allergy to fluorescein or soy;
clinically evident cognitive disabilities

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Addresses

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    • Charité Campus Benjamin Franklin
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Universitätsklinikum Schleswig-Holstein Campus Kiel
    • Ms.  Eylem  Oguz 
    • Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Jena Klinik für Innere Medizin IV mit Schwerpunkt Gastroenterologie, Hepatologie, Infektiologie, Klinikum Lobeda
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Horst-Schmidt-Kliniken Innere Medizin II, Gastroenterologie, Hepatologie, Endokrinologie
    • Susanne  Rudolph 
    • Ludwig-Ehrhard-Str. 100
    • 65199  Wiesbaden
    • Germany
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    • Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charite - Campus Benjamin Franklin
    • Mr.  Dr.  Reiner  Ullrich 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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    • Medizinische Klinik mit Schwerpunkt Gastroenterologie, Infektiologie und Rheumatologie, Charite - Campus Benjamin Franklin
    • Ms.  Cornelia  Krohn 
    • Hindenburgdamm 30
    • 12203  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/06/17
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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.