Trial document




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  DRKS00011674

Trial Description

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Title

Impact of intestinal microbiome on infections, course and outcome of haematological-oncological patients treated with chemotherapy

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Trial Acronym

MicroIntest

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URL of the Trial

http://-/-

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Brief Summary in Lay Language

In patients with a specific subtype of blood cancer (acute myeloid leukaemia, AML) the gut microbiome (i.e. the whole of the naturally occurring gut bacteria) should be to investigate concerning alteration due to chemotherapy and its side effects (here enteritis, mucositis) as well as antibiotics. It should be investigated how far an overgrowth of specific resistant or pathogenic bacteria, respectively, cause more infections. Furthermore, it should be investigated if the microbiome alterations have an impact on the course and outcome of the AML. To address these questions stool samples will be examined before, during and after chemotherapy cycles.

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Brief Summary in Scientific Language

Haematological-oncological patients are at high risk for infections due to the underlying disease and its therapy (chemotherapy, immunosuppressive therapy).

A required broad-spectrum antibiotic therapy promotes development and selection of multi-resistant bacteria. Screening measurements are necessary to prevent spread of multi-resistant bacteria or identify colonised patients, respectively. This means regular detection of multi-resistant Gram-negative rods (MRGN) in stool samples.

Adequate data on the impact of the microbiome concerning infection, course of disease and persistence of MRGN and Clostridium difficile are lacking. It seems that anti-Gram-positive agents have a negative impact on efficacy of some chemotherapeutic agents.

Stool samples of patients with acute myeloid leukaemia should be investigated on MRGN and other bacteria as well as the intestinal microbiome before, during and after chemotherapy.

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Organizational Data

  •   DRKS00011674
  •   2017/02/03
  •   [---]*
  •   yes
  •   Approved
  •   168/16, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1192-2282 
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Health Condition or Problem studied

  •   C92.0 -  Acute myeloblastic leukaemia [AML]
  •   gut microbiome
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Interventions/Observational Groups

  •   Investigation of stool samples regarding gut microbiome and multi-resistant bacteria of AML patients before, during and after intensive chemotherapy cycles (impact of chemotherapeutic agents and antibiotics on microbiome and multi-resistant bacteria); longitudinal inverstigation of several cycles
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1. Changes of intestinal microbiome after chemtherapy

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Secondary Outcome

1. Impact on course and outcome of disease;
2. Association between mixture of microbiome and MRGN colonisation or infection

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/02/13
  •   25
  •   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

1. Age ≥18 years;
2. Written informed consent;
3. AML first diagnose;
4. Therapy with repetitive chemotherapy cycles, inclusive allogeneic or autologous stem cell transplantation

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Exclusion Criteria

1. Antibiotic therapy ≤4 weeks before study inclusion;
2. AML teatment with cytoreductive long-term therapy (e. g. hydroxyurea);
3. Stool transplantation (e. g. due to relapsed C. difficile infection)

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Addresses

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Helmholtz-Zentrum für Infektionsforschung
    • Mr.  Dr.  Till  Strowig 
    • Inhoffenstraße 7
    • 39124  Braunschweig
    • Germany
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    • Otto-von-Guericke-Universität Magdeburg Medizinische FakultätZentrum für Innere MedizinKlinik für Hämatologie und Onkologie
    • Mr.  Dr. med.  Enrico  Schalk 
    • Leipziger Straße 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum Magdeburg A.ö.R.Klinik für Hämatologie und OnkologieStudiensekretariat
    • Ms.  Christine  Friedrichs 
    • Leipziger Straße 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Helmholtz-Zentrum für Infektionsforschung
    • Inhoffenstraße 7
    • 39124  Braunschweig
    • Germany
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Status

  •   Recruiting planned
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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.