Trial document




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  DRKS00008535

Trial Description

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Title

Changes of the gastrointestinal microbiome in perioperative patients

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Trial Acronym

GIMA-Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The microbiome is the majority of all the microorganisms the colonize in humans and in all other lifeforms. Modern techniques for sequencing DNA have enabled researchers to find the majority of these microbes - the majority of them cannot be cultured in a lab using current techniques. The human microbiome may have a role in auto-immune diseases like diabetes, rheumatoid arthritis, muscular dystrophy, multiple sclerosis, fibromyalgia, and perhaps some cancers.
The main issue of this study is to figure out how the gastrointestinal microbiom is changing during a perioperative process with antibiotic therapy and if there are any outcomerelevant changes.

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Brief Summary in Scientific Language

In this study the influence of an antibiotic therapy (single shot before the operation) in the gastrointestinal microbiome should be observed. Stool samples for a 16S RNA analyse and also all relevant clinical data will be collected in 150 patients undergoing a whipple operation at the time points preoperative, 1d, 3d, 5d, and 7d. At least we will perform a matched-pair Analyse, to compair 20 patients with a non-complicative and 20 patients with a complicative clinical course, to see how the microbiome changes are and if there are any outcomerelevant findings.

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Organizational Data

  •   DRKS00008535
  •   2015/10/28
  •   [---]*
  •   yes
  •   Approved
  •   S-119/2015, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   A41 -  Other sepsis
  •   C25 -  Malignant neoplasm of pancreas
  •   Z98 -  Other postsurgical states
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Interventions/Observational Groups

  •   Stool samples for a 16S RNA analyse and also all relevant clinical data will be collected in 150 patients undergoing a whipple operation at the time points preoperative, 1d, 3d, 5d, and 7d. Additionally an outcome reevaluation will be performed at the days 28 and 90.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Prognosis
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

*Changes in the gastrointestinal microbiome under antibiotic therapy (stool samples: preoperative, 1d, 3d, 5d, 7d)
*Comparison of the microbiome changes and clinical complications (preoperative, 1d, 3d, 5d, 7d)

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Secondary Outcome

*Comparison of the micobiome changes and outcomerelevance at the timepoints: preoperative, 1d, 3d, 5d, 7d (addditionally: reevaluation: 28d, 90d)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/11/01
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

*Written consent form of study participant or his appointed representative
*Age > 18 years
*undergoing a whipple-operation

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Exclusion Criteria

*Non-fulfillment of inclusion criteria
*chronic inflammatory diseases
*antibiotic allergies
*Refusal of participation in the study

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Alexander  Dalpke 
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum HeidelbergKlinik für Anästhesiologie
    • Mr.  Dr. med.  Felix Carl Fabian  Schmitt 
    • 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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* This entry means the parameter is not applicable or has not been set.