<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/NCT01683708</url>
  </required_header>
  <id_info>
    <org_study_id>Symbiotic2012</org_study_id>
    <nct_id>NCT01683708</nct_id>
  </id_info>
  <brief_title>Effectiveness Of Symbiotic Therapy In Jaundiced Patients</brief_title>
  <official_title>Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Ordine Mauriziano di Torino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Ordine Mauriziano di Torino</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study was therefore to evaluate if the perioperative administration of&#xD;
      symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for&#xD;
      hepato-biliary and pancreatic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite advances in preoperative patient's selection and anesthetic and surgical techniques,&#xD;
      surgery in jaundiced patients is associated with significant morbidity and mortality as a&#xD;
      consequence of septic complications. The evidence that nosocomial infections are frequently a&#xD;
      consequence of gut-derived organism such as enterobacteriaceae, supports the hypothesis of&#xD;
      the &quot;gut derived sepsis&quot;. Indeed, several studies have reported that jaundiced patients&#xD;
      present an increased intestinal permeability and consequently a higher rate of bacterial&#xD;
      migration from gastrointestinal tract across the lamina propria to local mesenteric lymph&#xD;
      nodes and from there to extra-intestinal site. This phenomenon increases after surgical&#xD;
      decompression of bile duct. The higher prevalence of bacterial translocation in jaundiced&#xD;
      patients is related to different mechanisms such as mucosal atrophy secondary to protracted&#xD;
      absence of intraluminal bile that open para-cellular route for bacterial translocation and&#xD;
      the decreased clearance capacity of Kuppfer secondary to cholestasis.&#xD;
&#xD;
      The mechanisms of action of symbiotics are largely unknown. The probiotic bacteria can&#xD;
      improve the mucosal barrier function reducing the bacterial translocation of organism to&#xD;
      mesenteric lymph nodes. Indeed symbiotic can affect the intestinal ecosystem by stimulating&#xD;
      mucosal immune and non-immune mechanisms through antagonism/competition with potential&#xD;
      pathogens.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2008</start_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Infectious Morbidity Rate</measure>
    <time_frame>Participants will followed for the duration of hospital stay, an expected average of 6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>IMMUNE PROFILE</measure>
    <time_frame>The day before and on postoperative day 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RATE OF TRANSLOCATION</measure>
    <time_frame>Intraoperative</time_frame>
    <description>a lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Postoperative Infections</condition>
  <condition>Jaundice</condition>
  <arm_group>
    <arm_group_label>Symbiotic group</arm_group_label>
    <description>Jaundiced patients who have symbiotic therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Symbiotic therapy</arm_group_label>
    <description>Jaundiced patients who not have symbiotic therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Symbiotic therapy</intervention_name>
    <description>Patients randomized into the Symbiotic group received Prebiotic® in a dose of one sachet twice a day for at least 1 week preoperatively. Postoperatively the medication was reintroduced as tolerated, and continued until discharge from hospital. One 4,5 gr sachet of Prebiotic® contains at least 1010 living Bifidobacterium bifidum, 1010 living Streptococcus Thermophilus, 1010 living Streptococcus Salivarius, 3 109 Lactobacillus Acidophilus, 1010 living Lactobacillus Casei, 1010 living Lactobacillus bulgaricus and galactooligosaccharides (4,5 gr).</description>
    <arm_group_label>Symbiotic group</arm_group_label>
    <other_name>Prebiotic® (Mediabase s.r.l., Prato, Italy)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Jaundiced patients scheduled for hepato-biliary pancreatic surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  jaundiced patients scheduled for elective extrahepatic bile duct resections&#xD;
&#xD;
          -  age between 18 and 80 year-old Exclusion Criteria:&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  cirrhosis&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) score 4&#xD;
&#xD;
          -  intestinal malabsorption&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  intolerance to symbiotic&#xD;
&#xD;
          -  diagnosis of primary or secondary immunodeficiency&#xD;
&#xD;
          -  unresectability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lorenzo Capussotti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mauriziano Hospital, Department of General and Oncological surgery</affiliation>
  </overall_official>
  <results_reference>
    <citation>Sugawara G, Nagino M, Nishio H, Ebata T, Takagi K, Asahara T, Nomoto K, Nimura Y. Perioperative synbiotic treatment to prevent postoperative infectious complications in biliary cancer surgery: a randomized controlled trial. Ann Surg. 2006 Nov;244(5):706-14. doi: 10.1097/01.sla.0000219039.20924.88.</citation>
    <PMID>17060763</PMID>
  </results_reference>
  <results_reference>
    <citation>Kanazawa H, Nagino M, Kamiya S, Komatsu S, Mayumi T, Takagi K, Asahara T, Nomoto K, Tanaka R, Nimura Y. Synbiotics reduce postoperative infectious complications: a randomized controlled trial in biliary cancer patients undergoing hepatectomy. Langenbecks Arch Surg. 2005 Apr;390(2):104-13. doi: 10.1007/s00423-004-0536-1. Epub 2005 Feb 12.</citation>
    <PMID>15711820</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 10, 2012</last_update_submitted>
  <last_update_submitted_qc>September 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Ordine Mauriziano di Torino</investigator_affiliation>
    <investigator_full_name>LorenzoCapussotti</investigator_full_name>
    <investigator_title>Director of Department of General and Oncologica Surgery</investigator_title>
  </responsible_party>
  <keyword>sepsis</keyword>
  <keyword>jaundice</keyword>
  <keyword>symbiotic</keyword>
  <keyword>translocation</keyword>
  <keyword>abdominal collection</keyword>
  <keyword>morbidity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaundice</mesh_term>
  </condition_browse>
  <!-- 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/NCT01683708
org study id: Symbiotic2012
nct id: NCT01683708
lead sponsor: 
has dmc: No
The aim of the present study was therefore to evaluate if the perioperative administration of
      symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for
      hepato-biliary and pancreatic surgery.
Despite advances in preoperative patient's selection and anesthetic and surgical techniques,
      surgery in jaundiced patients is associated with significant morbidity and mortality as a
      consequence of septic complications. The evidence that nosocomial infections are frequently a
      consequence of gut-derived organism such as enterobacteriaceae, supports the hypothesis of
      the "gut derived sepsis". Indeed, several studies have reported that jaundiced patients
      present an increased intestinal permeability and consequently a higher rate of bacterial
      migration from gastrointestinal tract across the lamina propria to local mesenteric lymph
      nodes and from there to extra-intestinal site. This phenomenon increases after surgical
      decompression of bile duct. The higher prevalence of bacterial translocation in jaundiced
      patients is related to different mechanisms such as mucosal atrophy secondary to protracted
      absence of intraluminal bile that open para-cellular route for bacterial translocation and
      the decreased clearance capacity of Kuppfer secondary to cholestasis.

      The mechanisms of action of symbiotics are largely unknown. The probiotic bacteria can
      improve the mucosal barrier function reducing the bacterial translocation of organism to
      mesenteric lymph nodes. Indeed symbiotic can affect the intestinal ecosystem by stimulating
      mucosal immune and non-immune mechanisms through antagonism/competition with potential
      pathogens.
observational model: Case-Control
time perspective: Prospective
measure: Infectious Morbidity Rate
time frame: Participants will followed for the duration of hospital stay, an expected average of 6 weeks
measure: IMMUNE PROFILE
time frame: The day before and on postoperative day 7
measure: RATE OF TRANSLOCATION
time frame: Intraoperative
description: a lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture
arm group label: Symbiotic group
description: Jaundiced patients who have symbiotic therapy
arm group label: No Symbiotic therapy
description: Jaundiced patients who not have symbiotic therapy
intervention type: Dietary Supplement
intervention name: Symbiotic therapy
description: Patients randomized into the Symbiotic group received Prebiotic® in a dose of one sachet twice a day for at least 1 week preoperatively. Postoperatively the medication was reintroduced as tolerated, and continued until discharge from hospital. One 4,5 gr sachet of Prebiotic® contains at least 1010 living Bifidobacterium bifidum, 1010 living Streptococcus Thermophilus, 1010 living Streptococcus Salivarius, 3 109 Lactobacillus Acidophilus, 1010 living Lactobacillus Casei, 1010 living Lactobacillus bulgaricus and galactooligosaccharides (4,5 gr).
arm group label: Symbiotic group
other name: Prebiotic® (Mediabase s.r.l., Prato, Italy)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lorenzo Capussotti, MD
role: Principal Investigator
affiliation: Mauriziano Hospital, Department of General and Oncological surgery
citation: Sugawara G, Nagino M, Nishio H, Ebata T, Takagi K, Asahara T, Nomoto K, Nimura Y. Perioperative synbiotic treatment to prevent postoperative infectious complications in biliary cancer surgery: a randomized controlled trial. Ann Surg. 2006 Nov;244(5):706-14. doi: 10.1097/01.sla.0000219039.20924.88.
PMID: 17060763
citation: Kanazawa H, Nagino M, Kamiya S, Komatsu S, Mayumi T, Takagi K, Asahara T, Nomoto K, Tanaka R, Nimura Y. Synbiotics reduce postoperative infectious complications: a randomized controlled trial in biliary cancer patients undergoing hepatectomy. Langenbecks Arch Surg. 2005 Apr;390(2):104-13. doi: 10.1007/s00423-004-0536-1. Epub 2005 Feb 12.
PMID: 15711820
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Ordine Mauriziano di Torino
investigator full name: LorenzoCapussotti
investigator title: Director of Department of General and Oncologica Surgery
mesh term: Jaundice