Trial document




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  DRKS00006810

Trial Description

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Title

Stool -therapy for inflammatory bowel disease

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The widespread use of antibiotic therapy has resulted both in Germany and worldwide to a significant increase in the incidence of Clostridium difficile (CD). CD infections (CDI), the most serious antibiotic-associated infection of the large intestine and the most common nosocomial infection of the digestive tract. Patients with microbiologically proven relapse of CDI is offered the stool therapy. The use of this therapy is voluntary and can be initiated independently of already started relapse therapy at any time. The stool for the treatment obtained from healthy donors after examination of the budget for these inclusion and exclusion criteria.

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Brief Summary in Scientific Language

Clostridium difficile (CDI) is the most serious antibiotic-associated infection of the large intestine and the most common nosocomial infection of the digestive tract. The broad application of antibiotic therapy has resulted in Germany and around the world to substantially increase the incidence of CDI. Currently provide symptomatic therapies such as lnfusionssubstitution, if possible discontinuation of triggering antibiotic therapy (eg, clindamycin, cephalosporins or quinolones) and antimicrobial therapy with oral metronidazole or oral vancomycin and newer antibiotic substance as fidaxomicin the standard of care. Despite the therapy suffer up to 25% the patient one or more recurrences. Essential mechanisms for this recurrence is the persistence of
Spores of CDI in the stool and antibiotic-induced dysregulation of physiological
Microbiome of the gut. The restoration of bowel microbioms of patients by transfer of physiological intestinal flora of a healthy person is considered possible alternative for over 50 years. Observational studies of the last two years have created high evidence for the effectiveness of the stool-therapy. In recent guidelines, the stool therapy has won a permanent place.

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Organizational Data

  •   DRKS00006810
  •   2014/10/07
  •   [---]*
  •   yes
  •   Approved
  •   109/14, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1161-3818 
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Health Condition or Problem studied

  •   A04.7 -  Enterocolitis due to Clostridium difficile
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Interventions/Observational Groups

  •   In dependence on the patient's request, two stool-administration routes are offered:
    1) Application via a nasoduodenale probe or 2) application via the endoscope during the Koloscopy (in the absence of decision by the patient or, in the case of an increased risk when performing a Koloscopy is the patient a duodenal application recommended).
    As a first step, the application is carried out by frozen stool, which was collected and frozen in advance of a healthy subject. The infusion mix is thawed only immediately before application. After therapy, patients are observed 24hours stationary and leave the hosptital with a stable clinical condition in the outpatient care, in so far as there are no other indications for inpatient treatment, dismissed.
    The follow-up of patients is provided for 90 days after therapy. C. difficile toxin stool test performed on days 14, 30, 90 or upon the occurrence of diarrhea. Sonographic examinations carried out for each bowel Visit the patient or on the same days as the CDI stool tests.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Evaluation the willingness of patients to perform a stool therapy by means of questionnaires on day -2 before therapy resp. Days 1, 3, 7, 14, 30, 90 after treatment

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Secondary Outcome

1. analysis of the molecular and microbiological changes in stool from the receiver (day -2 before therapy; day 14, 30, 90 after treatment)
2. influence on the susceptibility to allergies or respiratory function (day -2 before therapy; 30 days after treatment)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/03/02
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Patient information and consent
2. age> 18 years
3. Life expectancy> 6 months
4 Microbiological detection of CDI recurrence after at least an adequate standard antibiotic therapy with vancomycin> 125 mg / 4 times a day> 10 days or metronidazole 400 mg / 3 times a day
5. CDI-proof:
- Diarrhea (> 3 in two consecutive days)
- C. difficile toxin detection in stool

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Exclusion Criteria


1. Congenital or acquired immunodeficiency due to prolonged eg
Chemotherapy / drugs (eg, long-term therapy with prednisolone 60 mg)
2. stage HIV AIDS with CD4 cell counts below 250
3. pregnancy / lactation
4. Unstable circulatory condition (catecholamine / Respiratory
insufficiency)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
    • Mr.  Prof. Dr. med.  Ali  Canbay 
    • Leipziger Str. 44
    • Magdeburg  39120
    • Germany
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    • Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
    • Mr.  Dr. med.  Alexander  Link 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
    • Mr.  Dr. med.  Alexander  Link 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Gastroenterologie, Hepatologie und Infektiologie
    • Mr.  Prof. Dr. med.  Ali  Canbay 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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