Trial document




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  DRKS00011015

Trial Description

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Title

„Changes in the gastrointestinal microbiome after kidney transplantation"

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Trial Acronym

CIGAMI-NTX-Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Objective of the present trial is to research changes in patient’s gastrointestinal microbiome after kidney transplantation and therefore point out occuring immune mediated complications or possible reasons for damgage of graft.
Furthermore shall be examined in which extent the patient’s gastrointestinal microbiome will assimilate to the donor’s.
Sequencing of the gastrointestinal microbiome will be done of five stool samples separately taken from the patient, as well as one preoperative sample taken from the donor.

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Brief Summary in Scientific Language

Objective of the present trial is to research changes of the gastrointestinal microbiome to be used as predictive value for making estimation in matters of acceptance of graft as well as possible complications during the first days after performed kidney transplantation (graft from a living donor).
In this context, the gastrointestinal microbiome shall be sequenced before performance of transplantation as same as afterwards. Stool samples will be collected at following days: Before surgery (during consultation hour); T1 (first day after surgery); T3 (third day after surgery);
T5 (fifth day after surgery); T10 (tenth day after surgery).
2 grams of each stool sample will be extracted and successively processed during several steps.
Extraction of specific DNA will be performed after several further steps of cleaning and preparation of taken sample.
Amplification of DNA pieces will be performed using universal and bacterial primers.
Subsequently, sequencing of the microbiome will be performed via PCR as same as Next Generation Sequencing.

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Organizational Data

  •   DRKS00011015
  •   2016/10/31
  •   [---]*
  •   yes
  •   Approved
  •   S-063/2016, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   Z94.0 -  Kidney transplant status
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Interventions/Observational Groups

  •   patients with kidney transplantation (graft from a living donor):
    In this context, the gastrointestinal microbiome shall be sequenced before performance of transplantation as same as afterwards. Stool samples will be collected at following days:
    Before surgery (during consultation hour); T1 (first day after surgery); T3 (third day after surgery);
    T5 (fifth day after surgery); T10 (tenth day after surgery).
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Characteristics

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

Following points are being researched as a main criteria in patients after kidney transplantation performed at a german university medical center:

Sequencing of donor’s as well as graft receiving patient’s gastrointestinal microbiome via 16s RNA analysis.

To work out changes in receiving patient’s microbiome via 16S RNA analysis as a consequence of immunosuppressive therapy.

Stool samples will be collected at following days: Before surgery (during consultation hour); T1 (first day after surgery); T3 (third day after surgery);
T5 (fifth day after surgery); T10 (tenth day after surgery).

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Secondary Outcome

evaluation of possible connection between gastrointestinal microbiome and individual outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/12/01
  •   30
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

-Consent of agreement of participant
-patients undergoing a kidney transplantation (Graft from a living donor)

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Exclusion Criteria

missing satisfaction of inclusion criteria, pregnancy, HIV positive, denial of participation

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Addresses

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    • Klinik für AnästhesiologieUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Stefan  Hofer 
    • Im Neuenheimer Feld 410
    • 69120  Heidelberg
    • Germany
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    • Department für Infektiologie, Mikrobiologie und HygieneUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med  Alexander  Dalpke 
    • Im Neuenheimer Feld
    • 324  Heidelberg
    • Germany
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    • Klinik für AnaesthesiologieUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Stefan  Hofer 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinik für AnaesthesiologieUniversitätsklinikum Heidelberg
    • Mr.  Dr. med.  Felix  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für AnaesthesiologieUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Stefan  Hofer 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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