<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/NCT02990195</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_8914_RESCUE</org_study_id>
    <nct_id>NCT02990195</nct_id>
  </id_info>
  <brief_title>Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy</brief_title>
  <acronym>RESCUE</acronym>
  <official_title>Restoring the Beneficial Effects of Enterohepatic Bile Salt Signalling by Chyme Reinfusion in Patients With a Double Enterostomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maastricht University Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rennes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multicentre prospective human experimental study to determine the effect of chyme reinfusion&#xD;
      in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients supported by chyme reinfusion will be followed for 3 days pre chyme reinfusion and&#xD;
      for 7 weeks during chyme reinfusion. Three days prior chyme reinfusion, baseline&#xD;
      characteristics will be determined, an ileal biopsy, blood, chyme and urine will be&#xD;
      collected. Furthermore, blood, chyme, faeces and urine will be collected at the first day of&#xD;
      chime reinfusion. These materials will be collected again at week 1, 3, 5 and 7 weeks after&#xD;
      initiation of chyme reinfusion. A second ileal biopsy will be performed at week 3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">July 2, 2018</completion_date>
  <primary_completion_date type="Actual">July 2, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19</measure>
    <time_frame>Week 7</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of chyme reinfusion in patients with a double enterostomy on plasma bile salt levels</measure>
    <time_frame>Week 7</time_frame>
    <description>Measurement of bile salt</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of 7-alpha-hydroxy-4-cholesten-3-one (C4) plasma levels</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of bile salt composition in plasma</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of microbiotic profiling</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of citrulline plasma levels</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of intestinal-fatty acid binding protein (I-FABP) plasma levels</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of smooth muscle specific (SM) 22 plasma levels</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of chyme reinfusion in patients with a double enterostomy on liver function</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of lipopolysaccharide binding protein (LBP) plasma levels</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of plasma levels of inflammatory cytokines interleukin-6 (IL-6)</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of plasma levels of tumor necrosis factor-alpha (TNF-alpha)</measure>
    <time_frame>Week 7</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Double Enterostomy</condition>
  <arm_group>
    <arm_group_label>Double enterostomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chyme reinfusion</intervention_name>
    <arm_group_label>Double enterostomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age equal or above 18 years old&#xD;
&#xD;
          -  Temporary double enterostomy treated by chyme reinfusion as a routine primary care&#xD;
&#xD;
          -  Downstream bowel of at least 25 cm of healthy small bowel, accessible by a stoma, and&#xD;
             suitable for chyme reinfusion and ileal biopsy&#xD;
&#xD;
          -  In case of enterocutaneous fistula, diagnosis of fistula origin and localization&#xD;
             confirmed by additional medical imaging (computerized tomography/fistulography)&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a mental disability&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Hepatocellular carcinoma&#xD;
&#xD;
          -  Blood coagulation disorders&#xD;
&#xD;
          -  Shock of any cause&#xD;
&#xD;
          -  Patients subject to major legal protection (safeguarding justice, guardianship,&#xD;
             trusteeship), persons deprived of liberty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Yves</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University, Research Laboratories at the Department of General Surgery</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Netherlands</country>
  </location_countries>
  <results_reference>
    <citation>Koelfat KVK, Picot D, Chang X, Desille-Dugast M, van Eijk HM, van Kuijk SMJ, Lenicek M, Layec S, Carsin M, Dussaulx L, Seynhaeve E, Trivin F, Lacaze L, Thibault R, Schaap FG, Olde Damink SWM. Chyme Reinfusion Restores the Regulatory Bile Salt-FGF19 Axis in Patients With Intestinal Failure. Hepatology. 2021 Nov;74(5):2670-2683. doi: 10.1002/hep.32017. Epub 2021 Aug 26.</citation>
    <PMID>34133768</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02990195
org study id: 35RC16_8914_RESCUE
nct id: NCT02990195
lead sponsor: 
collaborator: 
has dmc: No
Multicentre prospective human experimental study to determine the effect of chyme reinfusion
      in patients with a double enterostomy on plasma levels of Fibroblast Growth Factor (FGF19)
Patients supported by chyme reinfusion will be followed for 3 days pre chyme reinfusion and
      for 7 weeks during chyme reinfusion. Three days prior chyme reinfusion, baseline
      characteristics will be determined, an ileal biopsy, blood, chyme and urine will be
      collected. Furthermore, blood, chyme, faeces and urine will be collected at the first day of
      chime reinfusion. These materials will be collected again at week 1, 3, 5 and 7 weeks after
      initiation of chyme reinfusion. A second ileal biopsy will be performed at week 3.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Effect of chyme reinfusion in patients with a double enterostomy on plasma levels of FGF19
time frame: Week 7
measure: Effect of chyme reinfusion in patients with a double enterostomy on plasma bile salt levels
time frame: Week 7
description: Measurement of bile salt
measure: Assessment of 7-alpha-hydroxy-4-cholesten-3-one (C4) plasma levels
time frame: Week 7
measure: Assessment of bile salt composition in plasma
time frame: Week 7
measure: Assessment of microbiotic profiling
time frame: Week 7
measure: Assessment of citrulline plasma levels
time frame: Week 7
measure: Assessment of intestinal-fatty acid binding protein (I-FABP) plasma levels
time frame: Week 7
measure: Assessment of smooth muscle specific (SM) 22 plasma levels
time frame: Week 7
measure: Effect of chyme reinfusion in patients with a double enterostomy on liver function
time frame: Week 7
measure: Assessment of lipopolysaccharide binding protein (LBP) plasma levels
time frame: Week 7
measure: Assessment of plasma levels of inflammatory cytokines interleukin-6 (IL-6)
time frame: Week 7
measure: Assessment of plasma levels of tumor necrosis factor-alpha (TNF-alpha)
time frame: Week 7
arm group label: Double enterostomy
arm group type: Other
intervention type: Other
intervention name: Chyme reinfusion
arm group label: Double enterostomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
country: Netherlands
citation: Koelfat KVK, Picot D, Chang X, Desille-Dugast M, van Eijk HM, van Kuijk SMJ, Lenicek M, Layec S, Carsin M, Dussaulx L, Seynhaeve E, Trivin F, Lacaze L, Thibault R, Schaap FG, Olde Damink SWM. Chyme Reinfusion Restores the Regulatory Bile Salt-FGF19 Axis in Patients With Intestinal Failure. Hepatology. 2021 Nov;74(5):2670-2683. doi: 10.1002/hep.32017. Epub 2021 Aug 26.
PMID: 34133768
responsible party type: Sponsor
sharing ipd: No