<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/NCT03011502</url>
  </required_header>
  <id_info>
    <org_study_id>MPBJI01</org_study_id>
    <nct_id>NCT03011502</nct_id>
  </id_info>
  <brief_title>InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS</brief_title>
  <acronym>OSIRIS</acronym>
  <official_title>InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MaaT Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MaaT Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota&#xD;
      imbalance, host-microbiota crosstalk dysfunction and inflammation.&#xD;
&#xD;
      As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly&#xD;
      interested in patients with Bone and Joint Infections (BJI). These patients are treated with&#xD;
      antibiotics having significant consequences on their intestinal flora, causing intestinal&#xD;
      discomfort, which can be manifested by diarrhea.&#xD;
&#xD;
      MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan&#xD;
      Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections&#xD;
      Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI).&#xD;
      The objective of this study is to follow patients with treated BJI in order to characterize&#xD;
      intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota&#xD;
      Transplantation (aFMT) intervention.&#xD;
&#xD;
      To do this, patients will be monitored according to the current CRIOAc recommendations, with&#xD;
      the aim of taking biological samples from patients at the same time as scheduled visits,&#xD;
      routine monitoring patients. Only one additional consultation will be carried out 15 days&#xD;
      after stopping the antibiotics in order to better evaluate the dysbiosis evolution.&#xD;
&#xD;
      Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up&#xD;
      consultations over a period of 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">March 27, 2018</completion_date>
  <primary_completion_date type="Actual">March 27, 2018</primary_completion_date>
  <phase>N/A</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>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution of intensity and frequency of Diarrheic Symptoms</measure>
    <time_frame>From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)</time_frame>
    <description>Assessment of the evolution of intensity and frequency of Diarrheic Symptoms from baseline, during antibiotic treatment (W2), at the end of treatment (W6-12) and 15 days after antibiotherapy treatment stop (W8-14)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method</measure>
    <time_frame>Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Bone and Joint Infection</condition>
  <arm_group>
    <arm_group_label>Experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biological samples collection of blood and feces</intervention_name>
    <arm_group_label>Experimental arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consenting subjects with BJI (native or material related BJI) at participating sites&#xD;
             who are being treated with antibiotics as part of their standard treatment procedure&#xD;
             will be enrolled&#xD;
&#xD;
          -  The subject is willing, able to understand and comply to the protocol requirement&#xD;
&#xD;
          -  More than 18-years-old&#xD;
&#xD;
          -  Subject is suspected for implanted or native BJI and is eligible for antibiotics&#xD;
             treatment&#xD;
&#xD;
          -  Subject signed Inform Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Severe disease with a life expectancy &lt; 3 months&#xD;
&#xD;
          -  Antibiotherapy in the 14 days before inclusion in the study&#xD;
&#xD;
          -  Patient non-affiliated to health care system&#xD;
&#xD;
          -  Patient under the power of law&#xD;
&#xD;
          -  Guardianship, curators patients&#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>Tristan Ferry, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpitaux civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCL Croix-Rousse</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GH Diaconesses-Croix Saint Simon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Tourcoing</name>
      <address>
        <city>Tourcoing</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Arthritis, Infectious</mesh_term>
    <mesh_term>Dysbiosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03011502
org study id: MPBJI01
nct id: NCT03011502
lead sponsor: 
has dmc: No
Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota
      imbalance, host-microbiota crosstalk dysfunction and inflammation.

      As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly
      interested in patients with Bone and Joint Infections (BJI). These patients are treated with
      antibiotics having significant consequences on their intestinal flora, causing intestinal
      discomfort, which can be manifested by diarrhea.

      MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan
      Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections
      Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI).
      The objective of this study is to follow patients with treated BJI in order to characterize
      intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota
      Transplantation (aFMT) intervention.

      To do this, patients will be monitored according to the current CRIOAc recommendations, with
      the aim of taking biological samples from patients at the same time as scheduled visits,
      routine monitoring patients. Only one additional consultation will be carried out 15 days
      after stopping the antibiotics in order to better evaluate the dysbiosis evolution.

      Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up
      consultations over a period of 6 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Evolution of intensity and frequency of Diarrheic Symptoms
time frame: From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)
description: Assessment of the evolution of intensity and frequency of Diarrheic Symptoms from baseline, during antibiotic treatment (W2), at the end of treatment (W6-12) and 15 days after antibiotherapy treatment stop (W8-14)
measure: Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method
time frame: Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months)
arm group label: Experimental arm
arm group type: Experimental
intervention type: Other
intervention name: Biological samples collection of blood and feces
arm group label: Experimental arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tristan Ferry, MD, PhD
role: Principal Investigator
affiliation: Hôpitaux civils de Lyon
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Arthritis, Infectious
mesh term: Dysbiosis
sharing ipd: Yes