<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03043339</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00092450</org_study_id>
    <secondary_id>16IPA1609418</secondary_id>
    <secondary_id>16IPA1609428</secondary_id>
    <nct_id>NCT03043339</nct_id>
  </id_info>
  <brief_title>Characterization Of the Intestinal Microbiome Evolution After Kidney Transplant Donation or Receipt</brief_title>
  <acronym>COMET-DR</acronym>
  <official_title>Characterization Of the Intestinal Microbiome Evolution After Kidney Transplant Donation or Receipt</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a hypothesis-generating pilot study. The intent is to model the impact of&#xD;
      perioperative practices on the intestinal microbiome and possibly associate these conditions&#xD;
      with the final microbiome status (e.g., number of resistance genes and diversity associated&#xD;
      with perioperative practices and preoperative microbiome status). Participants will include&#xD;
      individuals who are having surgery to either receive or donate a kidney. To determine the&#xD;
      diversity change of the intestinal microbiota over time, rectal swabs will be collected&#xD;
      before surgery and at several time points after surgery, with the last swab collected 30 days&#xD;
      after surgery.&#xD;
&#xD;
      This pilot study is to obtain preliminary data to support the rationale and design for a&#xD;
      subsequent clinical trial. This study is designed to understand the intestinal microbiota&#xD;
      diversity in the setting of renal transplant surgery and the clinical significance of&#xD;
      antibiotic use and the associated resistome (collection of all antibiotic resistance genes&#xD;
      and precursors within a sample).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The emergence of multidrug resistant organisms (MDROs) is a growing threat to global public&#xD;
      health and is associated with high morbidity and mortality in both the general and solid&#xD;
      organ transplant population. Intestinal microbiota diversity can provide functional and&#xD;
      spatial barriers to bacterial and fungal MDRO colonization, and loss of diversity is&#xD;
      associated with increased MDRO colonization. Dysbiosis is a state of loss of microbiota&#xD;
      diversity and a single antibiotic treatment course can cause significant disruption in&#xD;
      microbiota diversity, even in otherwise healthy individuals. This disruption can promote the&#xD;
      growth of pathogenic and multidrug-resistant bacteria and fungi. Transplant patients, in&#xD;
      particular, are at increased risk of colonization and infection with MDRO because of&#xD;
      immunomodulatory therapies, healthcare exposure, increased antibiotic exposure and surgical&#xD;
      manipulation of mucosa. Furthermore, chronic kidney disease and dialysis therapy leading up&#xD;
      to transplant has been shown to be associated with alterations in both the intestinal and&#xD;
      periodontal microbiome. Understanding the evolution of the disruption in the intestinal&#xD;
      microbiome in both kidney transplant recipients and healthy kidney transplant donors during&#xD;
      the time of transplant surgical prophylaxis will give valuable insight into further avenues&#xD;
      for research and possible interventions that may mitigate the risk of MDRO colonization.&#xD;
&#xD;
      This is a prospective, observational, and non-interventional pilot study which aims to enroll&#xD;
      100 adult renal transplant recipients and 100 adult renal transplant donors. Participants&#xD;
      will provide stool samples and anal swab samples, and will complete dietary questionnaires.&#xD;
      Participants may also choose to take part in an optional sub-study which involves banking&#xD;
      leftover stool for future research use.&#xD;
&#xD;
      The diversity change of the intestinal microbiota over time will be assessed at the screening&#xD;
      visit, Post-Operative Day 2; Post-Discharge Day 15 and Post-Discharge Day 30. Participants&#xD;
      will be followed by way of medical record review for 24 weeks post-surgery.&#xD;
&#xD;
      This study is designed to understand the intestinal microbiota diversity in the setting of&#xD;
      renal transplant surgery and the clinical significance of antibiotic use and the associated&#xD;
      resistome (collection of all antibiotic resistance genes and precursors within a sample).&#xD;
      Information learned from this study will be used to guide the design of future clinical&#xD;
      trials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in microbiota composition</measure>
    <time_frame>Baseline to Postoperative Day 30</time_frame>
    <description>To understand the overall impact of surgical prophylaxis on intestinal microbiota composition in the setting of renal transplant surgery, the distribution and relative abundance of bacterial and fungal taxa for each collected sample will be described. A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in microbiota diversity</measure>
    <time_frame>Baseline to Postoperative Day 30</time_frame>
    <description>To understand the overall impact of surgical prophylaxis on intestinal microbiota diversity in the setting of renal transplant surgery, measures of α- and β-diversity of the intestinal microbiota will be utilized. The maximum percentage of all genes identified included within the same taxon will be determined from each stool sample.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in microbiota taxonomy</measure>
    <time_frame>Baseline to Postoperative Day 30</time_frame>
    <description>To understand the overall impact of surgical prophylaxis on intestinal microbiota taxonomy, in the setting of renal transplant surgery, the collected specimens will be used for taxonomic composition determination of bacteria and fungi. Whole genome shotgun metagenomic sequencing will be performed on an Illumina Miseq (or HiSeq). A short read mapper will be used to screen out and discard human sequences from each stool sample and subsequently Metaphlan and KRAKEN are used for taxonomic composition determination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in microbiota resistome</measure>
    <time_frame>Baseline to Postoperative Day 30</time_frame>
    <description>To understand the overall impact of surgical prophylaxis on intestinal microbiota resistance, in the setting of renal transplant surgery, the study samples collected will be used to provide a summary of the overall number and diversity of bacterial and fungal resistance genes, including any new acquisition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiota composition in renal dialysis patients</measure>
    <time_frame>Baseline</time_frame>
    <description>To understand the intestinal microbiota composition in patients receiving renal dialysis, the distribution and relative abundance of bacterial and fungal taxa for each collected sample will be described. A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample collected at baseline (prior to renal transplant).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota diversity in renal dialysis patients</measure>
    <time_frame>Baseline</time_frame>
    <description>To understand the intestinal microbiota Alpha and Beta diversity in patients receiving renal dialysis, the maximum percentage of all genes identified included within the same taxon will be determined from the study samples collected at baseline (prior to renal transplant).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Microbiota resistome in renal dialysis patients</measure>
    <time_frame>Baseline</time_frame>
    <description>To understand the intestinal microbiota resistance in patients receiving renal dialysis, the study samples collected at baseline (prior to renal transplant) will be used to provide a summary of the overall number and diversity of bacterial resistance genes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Compare microbiota composition of donors and recipients</measure>
    <time_frame>Baseline</time_frame>
    <description>The exploratory objective of this study is to characterize the similarities and differences in intestinal microbiota between living donor and recipients at the baseline time point. The distribution and relative abundance of bacterial and fungal taxa for each baseline sample (prior to renal transplant) will be described. A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample.</description>
  </other_outcome>
  <other_outcome>
    <measure>Compare microbiota diversity of donors and recipients</measure>
    <time_frame>Baseline</time_frame>
    <description>The exploratory objective of this study is to characterize the similarities and differences in intestinal microbiota between living donor and recipients at the baseline time point. The maximum percentage of all genes identified included within the same taxon will be determined from each stool sample collected prior to renal transplant.</description>
  </other_outcome>
  <other_outcome>
    <measure>Compare microbiota taxonomy of donors and recipients</measure>
    <time_frame>Baseline</time_frame>
    <description>The exploratory objective of this study is to characterize the similarities and differences in intestinal microbiota between living donor and recipients at the baseline time point. The study samples collected will be used for taxonomic composition determination of bacteria and fungi. Whole genome shotgun metagenomic sequencing will be performed on an Illumina Miseq (or HiSeq). A short read mapper will be used to screen out and discard human sequences from each stool sample and subsequently Metaphlan and KRAKEN are used for taxonomic composition determination.</description>
  </other_outcome>
  <other_outcome>
    <measure>Compare microbiota resistome of donors and recipients</measure>
    <time_frame>Baseline</time_frame>
    <description>The exploratory objective of this study is to characterize the similarities and differences in intestinal microbiota between living donor and recipients at the baseline time point. The study samples collected will be used to provide a summary of the overall number and diversity of bacterial and fungal resistance genes, including any new acquisition.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Renal Transplant</condition>
  <arm_group>
    <arm_group_label>Renal transplant recipient</arm_group_label>
    <description>Participants who are scheduled for a planned renal transplant as the recipient of the kidney.&#xD;
All participants will complete the following interventions:&#xD;
Stool Specimen Collection&#xD;
Anal Swab Sampling&#xD;
Short Diet Assessment (SDA)&#xD;
NHANES Dietary Screener Questionnaire (DSQ)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Renal transplant donor</arm_group_label>
    <description>Participants who are scheduled for a planned renal transplant as the donor of the kidney.&#xD;
All participants will complete the following interventions:&#xD;
Stool Specimen Collection&#xD;
Anal Swab Sampling&#xD;
Short Diet Assessment (SDA)&#xD;
NHANES Dietary Screener Questionnaire (DSQ)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stool Specimen Collection</intervention_name>
    <description>Participants will provide a stool sample at baseline (pre-operation) and 30 days after the transplant operation. Stool specimens will be self-collected by the participant.</description>
    <arm_group_label>Renal transplant donor</arm_group_label>
    <arm_group_label>Renal transplant recipient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anal Swab Sampling</intervention_name>
    <description>Anal swabs will be collected prior to surgery (baseline) and at post-operation days 2, 15, and 30. Participants whose planned hospitalization duration is extended from the pre-surgical plan will have an additional, optional, anal swab collected 2 days prior to their anticipated hospital discharge date. Anal swabs will be collected by the study team, except for the standard of care post-operative appointment (30 days after the operation) for the living donors who will collect their own samples.</description>
    <arm_group_label>Renal transplant donor</arm_group_label>
    <arm_group_label>Renal transplant recipient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Short Diet Assessment (SDA)</intervention_name>
    <description>The study coordinator will administer the Short Diet Assessment (SDA) to participants prior to surgery at baseline and post-operation days 2, 15, and 30. Participants whose planned hospital length of stay is extended from the pre-surgical plan will complete the questionnaire 2 days prior to their anticipated hospital discharge date.</description>
    <arm_group_label>Renal transplant donor</arm_group_label>
    <arm_group_label>Renal transplant recipient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NHANES Dietary Screener Questionnaire (DSQ)</intervention_name>
    <description>The National Health and Nutrition Examination Survey (NHANES) 2009-2010 Dietary Screener Questionnaire will be completed on Post-Operative Day 2. The questionnaire asks about foods consumed during the past 30 days. There are 25 items on the questionnaire and additional questions may be asked depending on responses provided. The questionnaire will be self-administered or administered by a study team member.</description>
    <arm_group_label>Renal transplant donor</arm_group_label>
    <arm_group_label>Renal transplant recipient</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Specimens collected through anal swabs and stool samples will be stored until DNA extraction&#xD;
      can occur. DNA analysis of the microbiome will occur; DNA of the participants will not be&#xD;
      examined.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Renal transplant recipients and living donors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
&#xD;
          -  Ability and willingness to comply with study protocol requirements.&#xD;
&#xD;
          -  Completed Verbal Screening Form&#xD;
&#xD;
          -  Planned kidney donation or planned receipt of a living donor kidney transplant within&#xD;
             28 days from time of written informed consent.&#xD;
&#xD;
          -  If performance status is known, a score of any of the following:&#xD;
&#xD;
               -  American Society of Anesthesia (ASA) classification of I (a normal healthy&#xD;
                  patient), II (a patient with mild systemic disease) or III (a patient with severe&#xD;
                  systemic disease)&#xD;
&#xD;
               -  Eastern Cooperative Oncology Group (ECOG) Status Scale grade of 0 (normal&#xD;
                  activity), 1 (symptoms, but ambulatory) or 2 (in bed &lt;50% of the time)&#xD;
&#xD;
               -  Karnofsky Performance Scale (KPS) of 50% (requires considerable assistance and&#xD;
                  frequent medical care) to 100% (normal, no complaints, no evidence of disease)&#xD;
&#xD;
          -  English speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, might interfere with study&#xD;
             objectives or limit compliance with study requirements, including but not limited to:&#xD;
&#xD;
               -  Known active intravenous drug or alcohol abuse&#xD;
&#xD;
               -  Psychiatric illness&#xD;
&#xD;
               -  Social situation&#xD;
&#xD;
          -  Planned or actual receipt of a deceased donor kidney transplant.&#xD;
&#xD;
          -  Prior kidney transplant that still requires active immunosuppressive treatment or&#xD;
             intervention.&#xD;
&#xD;
          -  Presence of diverting ileostomy or colostomy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colleen S Kraft, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Colleen S Kraft, MD, MSc</last_name>
    <phone>404-712-8889</phone>
    <email>colleen.kraft@emory.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Emory Clinic</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Colleen S Kraft, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30324</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Colleen S. Kraft, MD, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Colleen S. Kraft</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Microbiota composition</keyword>
  <keyword>Kidney transplant recipient</keyword>
  <keyword>Kidney transplant donor</keyword>
  <keyword>Antibiotics</keyword>
  <keyword>Drug resistance</keyword>
  <keyword>Transplantation surgery</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03043339
org study id: IRB00092450
secondary id: 16IPA1609418
secondary id: 16IPA1609428
nct id: NCT03043339
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a hypothesis-generating pilot study. The intent is to model the impact of
      perioperative practices on the intestinal microbiome and possibly associate these conditions
      with the final microbiome status (e.g., number of resistance genes and diversity associated
      with perioperative practices and preoperative microbiome status). Participants will include
      individuals who are having surgery to either receive or donate a kidney. To determine the
      diversity change of the intestinal microbiota over time, rectal swabs will be collected
      before surgery and at several time points after surgery, with the last swab collected 30 days
      after surgery.

      This pilot study is to obtain preliminary data to support the rationale and design for a
      subsequent clinical trial. This study is designed to understand the intestinal microbiota
      diversity in the setting of renal transplant surgery and the clinical significance of
      antibiotic use and the associated resistome (collection of all antibiotic resistance genes
      and precursors within a sample).
The emergence of multidrug resistant organisms (MDROs) is a growing threat to global public
      health and is associated with high morbidity and mortality in both the general and solid
      organ transplant population. Intestinal microbiota diversity can provide functional and
      spatial barriers to bacterial and fungal MDRO colonization, and loss of diversity is
      associated with increased MDRO colonization. Dysbiosis is a state of loss of microbiota
      diversity and a single antibiotic treatment course can cause significant disruption in
      microbiota diversity, even in otherwise healthy individuals. This disruption can promote the
      growth of pathogenic and multidrug-resistant bacteria and fungi. Transplant patients, in
      particular, are at increased risk of colonization and infection with MDRO because of
      immunomodulatory therapies, healthcare exposure, increased antibiotic exposure and surgical
      manipulation of mucosa. Furthermore, chronic kidney disease and dialysis therapy leading up
      to transplant has been shown to be associated with alterations in both the intestinal and
      periodontal microbiome. Understanding the evolution of the disruption in the intestinal
      microbiome in both kidney transplant recipients and healthy kidney transplant donors during
      the time of transplant surgical prophylaxis will give valuable insight into further avenues
      for research and possible interventions that may mitigate the risk of MDRO colonization.

      This is a prospective, observational, and non-interventional pilot study which aims to enroll
      100 adult renal transplant recipients and 100 adult renal transplant donors. Participants
      will provide stool samples and anal swab samples, and will complete dietary questionnaires.
      Participants may also choose to take part in an optional sub-study which involves banking
      leftover stool for future research use.

      The diversity change of the intestinal microbiota over time will be assessed at the screening
      visit, Post-Operative Day 2; Post-Discharge Day 15 and Post-Discharge Day 30. Participants
      will be followed by way of medical record review for 24 weeks post-surgery.

      This study is designed to understand the intestinal microbiota diversity in the setting of
      renal transplant surgery and the clinical significance of antibiotic use and the associated
      resistome (collection of all antibiotic resistance genes and precursors within a sample).
      Information learned from this study will be used to guide the design of future clinical
      trials.
observational model: Other
time perspective: Prospective
measure: Change in microbiota composition
time frame: Baseline to Postoperative Day 30
description: To understand the overall impact of surgical prophylaxis on intestinal microbiota composition in the setting of renal transplant surgery, the distribution and relative abundance of bacterial and fungal taxa for each collected sample will be described. A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample.
measure: Change in microbiota diversity
time frame: Baseline to Postoperative Day 30
description: To understand the overall impact of surgical prophylaxis on intestinal microbiota diversity in the setting of renal transplant surgery, measures of α- and β-diversity of the intestinal microbiota will be utilized. The maximum percentage of all genes identified included within the same taxon will be determined from each stool sample.
measure: Change in microbiota taxonomy
time frame: Baseline to Postoperative Day 30
description: To understand the overall impact of surgical prophylaxis on intestinal microbiota taxonomy, in the setting of renal transplant surgery, the collected specimens will be used for taxonomic composition determination of bacteria and fungi. Whole genome shotgun metagenomic sequencing will be performed on an Illumina Miseq (or HiSeq). A short read mapper will be used to screen out and discard human sequences from each stool sample and subsequently Metaphlan and KRAKEN are used for taxonomic composition determination.
measure: Change in microbiota resistome
time frame: Baseline to Postoperative Day 30
description: To understand the overall impact of surgical prophylaxis on intestinal microbiota resistance, in the setting of renal transplant surgery, the study samples collected will be used to provide a summary of the overall number and diversity of bacterial and fungal resistance genes, including any new acquisition.
measure: Microbiota composition in renal dialysis patients
time frame: Baseline
description: To understand the intestinal microbiota composition in patients receiving renal dialysis, the distribution and relative abundance of bacterial and fungal taxa for each collected sample will be described. A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample collected at baseline (prior to renal transplant).
measure: Microbiota diversity in renal dialysis patients
time frame: Baseline
description: To understand the intestinal microbiota Alpha and Beta diversity in patients receiving renal dialysis, the maximum percentage of all genes identified included within the same taxon will be determined from the study samples collected at baseline (prior to renal transplant).
measure: Microbiota resistome in renal dialysis patients
time frame: Baseline
description: To understand the intestinal microbiota resistance in patients receiving renal dialysis, the study samples collected at baseline (prior to renal transplant) will be used to provide a summary of the overall number and diversity of bacterial resistance genes.
measure: Compare microbiota composition of donors and recipients
time frame: Baseline
description: The exploratory objective of this study is to characterize the similarities and differences in intestinal microbiota between living donor and recipients at the baseline time point. The distribution and relative abundance of bacterial and fungal taxa for each baseline sample (prior to renal transplant) will be described. A genus of strain will be considered predominant if it represents at least 30% of all genus or strains of microbiota within the stool sample.
measure: Compare microbiota diversity of donors and recipients
time frame: Baseline
description: The exploratory objective of this study is to characterize the similarities and differences in intestinal microbiota between living donor and recipients at the baseline time point. The maximum percentage of all genes identified included within the same taxon will be determined from each stool sample collected prior to renal transplant.
measure: Compare microbiota taxonomy of donors and recipients
time frame: Baseline
description: The exploratory objective of this study is to characterize the similarities and differences in intestinal microbiota between living donor and recipients at the baseline time point. The study samples collected will be used for taxonomic composition determination of bacteria and fungi. Whole genome shotgun metagenomic sequencing will be performed on an Illumina Miseq (or HiSeq). A short read mapper will be used to screen out and discard human sequences from each stool sample and subsequently Metaphlan and KRAKEN are used for taxonomic composition determination.
measure: Compare microbiota resistome of donors and recipients
time frame: Baseline
description: The exploratory objective of this study is to characterize the similarities and differences in intestinal microbiota between living donor and recipients at the baseline time point. The study samples collected will be used to provide a summary of the overall number and diversity of bacterial and fungal resistance genes, including any new acquisition.
arm group label: Renal transplant recipient
description: Participants who are scheduled for a planned renal transplant as the recipient of the kidney.
All participants will complete the following interventions:
Stool Specimen Collection
Anal Swab Sampling
Short Diet Assessment (SDA)
NHANES Dietary Screener Questionnaire (DSQ)
arm group label: Renal transplant donor
description: Participants who are scheduled for a planned renal transplant as the donor of the kidney.
All participants will complete the following interventions:
Stool Specimen Collection
Anal Swab Sampling
Short Diet Assessment (SDA)
NHANES Dietary Screener Questionnaire (DSQ)
intervention type: Other
intervention name: Stool Specimen Collection
description: Participants will provide a stool sample at baseline (pre-operation) and 30 days after the transplant operation. Stool specimens will be self-collected by the participant.
arm group label: Renal transplant donor
arm group label: Renal transplant recipient
intervention type: Other
intervention name: Anal Swab Sampling
description: Anal swabs will be collected prior to surgery (baseline) and at post-operation days 2, 15, and 30. Participants whose planned hospitalization duration is extended from the pre-surgical plan will have an additional, optional, anal swab collected 2 days prior to their anticipated hospital discharge date. Anal swabs will be collected by the study team, except for the standard of care post-operative appointment (30 days after the operation) for the living donors who will collect their own samples.
arm group label: Renal transplant donor
arm group label: Renal transplant recipient
intervention type: Other
intervention name: Short Diet Assessment (SDA)
description: The study coordinator will administer the Short Diet Assessment (SDA) to participants prior to surgery at baseline and post-operation days 2, 15, and 30. Participants whose planned hospital length of stay is extended from the pre-surgical plan will complete the questionnaire 2 days prior to their anticipated hospital discharge date.
arm group label: Renal transplant donor
arm group label: Renal transplant recipient
intervention type: Other
intervention name: NHANES Dietary Screener Questionnaire (DSQ)
description: The National Health and Nutrition Examination Survey (NHANES) 2009-2010 Dietary Screener Questionnaire will be completed on Post-Operative Day 2. The questionnaire asks about foods consumed during the past 30 days. There are 25 items on the questionnaire and additional questions may be asked depending on responses provided. The questionnaire will be self-administered or administered by a study team member.
arm group label: Renal transplant donor
arm group label: Renal transplant recipient
Specimens collected through anal swabs and stool samples will be stored until DNA extraction
      can occur. DNA analysis of the microbiome will occur; DNA of the participants will not be
      examined.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Colleen S Kraft, MD, MSc
role: Principal Investigator
affiliation: Emory University
last name: Colleen S Kraft, MD, MSc
phone: 404-712-8889
email: colleen.kraft@emory.edu
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Colleen S. Kraft
investigator title: Associate Professor
sharing ipd: No