xml: <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/NCT06040515</url>
    </required_header>
    <id_info>
      <org_study_id>EcN2023</org_study_id>
      <nct_id>NCT06040515</nct_id>
    </id_info>
    <brief_title>Probiotic After Acute Colonic Diverticulitis</brief_title>
    <official_title>Probiotic EcN in Symptomatic Patients After an Episode of Acute Colonic Diverticulitis: a Prospective Multicentre Observational Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmo Spaziani</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Roma La Sapienza</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this observational study is to assess the efficacy and safety of the probiotic&#xD;
        Escherichia coli Nissle 1917 (EcN®, Ca.Di.Group S.p.A) in the treatment of symptomatic&#xD;
        patients after an episode of both complicated and uncomplicated acute colonic diverticulitis.&#xD;
  &#xD;
        The main question it aims to answer are:&#xD;
  &#xD;
          -  Is the studied probiotic able to significantly reduce symptoms, assessed by means of a&#xD;
             validated and dedicated score?&#xD;
  &#xD;
          -  Is there any difference in microbiota among the study group at baseline and a selected&#xD;
             cohort of patients subdivided in subjects with diverticulosis and asymptomatic subjects&#xD;
             after an episode of acute uncomplicated diverticulitis or an episode of complicated&#xD;
             diverticulitis submitted to surgery with colonic resection without stoma?&#xD;
  &#xD;
          -  Is there any difference in microbiota in the study group at baseline and after 3 and 6&#xD;
             months of treatment with the probiotic?&#xD;
  &#xD;
          -  Is there any correlation between microbiota modification and symptoms during follow-up?&#xD;
  &#xD;
          -  Is there any impact on fecal calprotectin values before and during probiotic therapy?&#xD;
  &#xD;
          -  Is there any modification of evacuation before and during follow-up?&#xD;
  &#xD;
          -  Is probiotic able to prevent recurrent episodes of acute diverticulitis during&#xD;
             follow-up?&#xD;
  &#xD;
          -  The safety of the probiotic will be assessed during the follow-up. The study group will&#xD;
             be assessed at baseline and during follow-up with a dedicated clinical score and Bristol&#xD;
             stool scale. Microbiota and fecal calprotectin values will be also assessed at baseline&#xD;
             and during follow-up. Microbiota at baseline will be also evaluated for comparison in&#xD;
             the three selected groups with diverticulosis and both asymptomatic and symptomatic&#xD;
             after an episode of acute diverticulitis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917</measure>
      <time_frame>Six-months follow-up</time_frame>
      <description>Median symptomatic score assessed at baseline and during follow-up</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Microbiota qualitative composition</measure>
      <time_frame>Baseline</time_frame>
      <description>Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microbiota qualitative composition modification</measure>
      <time_frame>Baseline and during 6-month follow-up.</time_frame>
      <description>Composition of microbiota will be assessed in symptomatic study groups with a dedicated kit for collection.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Microbiota qualitative composition and median symptomatic score correlation</measure>
      <time_frame>Baseline and during 6-month follow-up.</time_frame>
      <description>Correlation between the median symptomatic score and qualitative composition of microbiota modification after therapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of fecal calprotectin</measure>
      <time_frame>Baseline and during 6-month follow-up.</time_frame>
      <description>Assessment of fecal calprotectin concentration in the symptomatic study group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bristol stool scale modification</measure>
      <time_frame>Baseline and during 6-month follow-up.</time_frame>
      <description>Assessment of median Bristol stool scale in the symptomatic study group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevention of recurrent acute diverticulitis</measure>
      <time_frame>Six-month follow-up.</time_frame>
      <description>Number off patients with recurrent acute diverticulitis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety</measure>
      <time_frame>Six-month follow-up.</time_frame>
      <description>Number of patients with adverse events.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">145</enrollment>
    <condition>Diverticulitis, Colonic</condition>
    <condition>Therapy</condition>
    <arm_group>
      <arm_group_label>Symptomatic patients after acute diverticulitis</arm_group_label>
      <description>Patients aged ≥18 with persistent symptoms at least three months after a radiologic and/or endoscopic documented acute diverticulitis or after six months of surgery for complicated acute diverticulitis.&#xD;
  Therapy with Escherichia coli Nissle 1917 (EcN®) will be prescribed for a global duration of six months with the following assumption schedule: 2 capsules b.i.d. during 4 weeks, followed by 1 capsule o.i.d during 20 days each month for 5 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Diverticulosis</arm_group_label>
      <description>Patients with asymptomatic diverticulosis. No therapy will be administered. Microbiota assessment will be performed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Asymptomatic patients after acute uncomplicated diverticulitis</arm_group_label>
      <description>Asymptomatic patients assessed three months after an episode of acute uncomplicated diverticulitis. No therapy will be administered. Microbiota assessment will be performed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Asymptomatic patients after acute complicated diverticulitis</arm_group_label>
      <description>Asymptomatic patients assessed six months after an episode of acute complicated diverticulitis submitted to surgery with resection and without stoma . No therapy will be administered. Microbiota assessment will be performed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Probiotic Formula</intervention_name>
      <description>Capsule with 25 billion live strains of Escherichia coli Nissle 1917</description>
      <arm_group_label>Symptomatic patients after acute diverticulitis</arm_group_label>
      <other_name>Escherichia coli Nissle 1917</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Stool&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will include the above specified study groups.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Symptomatic patients three months after an episode of uncomplicated acute colonic&#xD;
               diverticulitis;&#xD;
  &#xD;
            -  Symptomatic patients six months after an episode of complicated acute colonic&#xD;
               diverticulitis; submitted to .surgical colonic resection without stoma;&#xD;
  &#xD;
            -  Patients with diverticulosis;&#xD;
  &#xD;
            -  Asymptomatic patients three months after an episode of uncomplicated acute colonic&#xD;
               diverticulitis;&#xD;
  &#xD;
            -  Asymptomatic patients six months after an episode of complicated acute colonic&#xD;
               diverticulitis; submitted to surgical colonic resection without stoma.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Ongoing acute diverticulitis at radiologic assessment&#xD;
  &#xD;
            -  Antibiotic therapy, both systemic and topic, and/or probiotics and/or mesalazine&#xD;
               within four weeks before enrolment;&#xD;
  &#xD;
            -  Lactulose-lactitol use within four weeks before enrolment;&#xD;
  &#xD;
            -  Presence of chronic inflammatory bowel diseases;&#xD;
  &#xD;
            -  Presence of Segmental Colitis Associated with Diverticulitis (SCAD);&#xD;
  &#xD;
            -  Presence of ischemic colitis;&#xD;
  &#xD;
            -  Severe chronic liver (Child-Pugh C) and/or pancreatic and/or renal diseases;&#xD;
  &#xD;
            -  Patients with severe renal failure;&#xD;
  &#xD;
            -  Presence of suspected/actual pregnancy;&#xD;
  &#xD;
            -  Presence of recent/ongoing neoplasia, under oncological treatment within 6 months&#xD;
               before enrolment;&#xD;
  &#xD;
            -  Presence of COVID-19 infection;&#xD;
  &#xD;
            -  Patients unable to give informed consent.&#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>Walter Elisei, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>• UOC di Gastroenterologia, Azienda Ospedaliera &quot;S. Camillo-Forlanini&quot;, Roma</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Antonio Tursi, MD, PhD</last_name>
      <phone>+393473490583</phone>
      <email>antotursi@tiscali.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marcello Picchio, MD</last_name>
      <phone>+393392371293</phone>
      <email>marcellopicchio@libero.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale &quot;Pugliese-Ciaccio</name>
        <address>
          <city>Catanzaro</city>
          <state>Calabria</state>
          <zip>88100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stefano Rodinò, MD, PhD</last_name>
        <email>srodino@tin.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UOSVD di Endoscopia Digestiva, Ospedale &quot;S. Maria Goretti&quot;</name>
        <address>
          <city>Latina</city>
          <state>Lazio</state>
          <zip>04100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Giuseppe Pianese</last_name>
        <email>pianesepino@libero.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UOC di Gastroenterologia, Azienda Ospedaliera &quot;S. Camillo-Forlanini&quot;</name>
        <address>
          <city>Roma</city>
          <state>Lazio</state>
          <zip>00152</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Roberto Faggiani, MD, PhD</last_name>
        <email>faggiani.r@tin.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale &quot;Umberto I&quot;</name>
        <address>
          <city>Roma</city>
          <state>Lazio</state>
          <zip>00161</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Antonio Cuomo, MD, PhD</last_name>
        <email>drcuomo@iol.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UOC di Medicina Interna e Gastroenterologia, Ospedale &quot;Cristo Re&quot;</name>
        <address>
          <city>Roma</city>
          <state>Lazio</state>
          <zip>00167</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Giovanni Brandimarte, MD, PhD</last_name>
        <email>giovannibrandimarte56@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UOC Chirurgia Generale, Ospedale &quot;P. Colombo&quot;</name>
        <address>
          <city>Velletri</city>
          <state>Lazio</state>
          <zip>00049</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marcello Picchio, MD</last_name>
        <email>marcellopicchio@libero.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UOC di Gastroenterologia, Ospedale &quot;Belcolle&quot;,</name>
        <address>
          <city>Viterbo</city>
          <state>Lazio</state>
          <zip>01100</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Costantino Zampaletta</last_name>
        <email>zcosta@libero.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>• UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale Universitario &quot;San Raffaele&quot;</name>
        <address>
          <city>Milan</city>
          <state>Lombardia</state>
          <zip>20132</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Silvio Danese, MD, PhD</last_name>
        <email>sdanese@hotmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova</name>
        <address>
          <city>Padova</city>
          <state>Lombardia</state>
          <zip>35031</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Edoardo V. Savarino, MD, PhD</last_name>
        <email>edoardo.savarino@unipd.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UOC di Gastroenterologia, Ospedale &quot;Guglielmo da Saliceto&quot;</name>
        <address>
          <city>Piacenza</city>
          <state>Lombardia</state>
          <zip>29121</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Giovanni Aragona, MD, PhD</last_name>
        <email>g.aragona@ausl.pc.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>UOC di Gastroenterologia, Ospedale &quot;S. Salvatore&quot;,</name>
        <address>
          <city>Pesaro</city>
          <state>Marche</state>
          <zip>61121</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Antonella Scarcelli, MD</last_name>
        <email>antonella.scarcelli@ospedalimarchenord.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Gastroenterology Service , ASL BAT,</name>
        <address>
          <city>Andria</city>
          <zip>76123</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Antonio Tursi, MD</last_name>
        <email>antotursi@tiscali.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <results_reference>
      <citation>Kvasnovsky CL, Adams K, Papagrigoriadis S. Diverticular disease as a chronic gastrointestinal condition: experience from a specialist clinic. Eur J Gastroenterol Hepatol. 2015 Apr;27(4):442-8. doi: 10.1097/MEG.0000000000000304.</citation>
      <PMID>25874519</PMID>
    </results_reference>
    <results_reference>
      <citation>Mj O, Turner GA, A S, Frizelle FA, R P. Distinct changes in the colonic microbiome associated with acute diverticulitis. Colorectal Dis. 2022 Dec;24(12):1591-1601. doi: 10.1111/codi.16271. Epub 2022 Aug 11.</citation>
      <PMID>35950499</PMID>
    </results_reference>
    <results_reference>
      <citation>Tursi A, Papa V, Lopetuso LR, Settanni CR, Gasbarrini A, Papa A. Microbiota Composition in Diverticular Disease: Implications for Therapy. Int J Mol Sci. 2022 Nov 26;23(23):14799. doi: 10.3390/ijms232314799.</citation>
      <PMID>36499127</PMID>
    </results_reference>
    <results_reference>
      <citation>Teng G, Liu Z, Liu Y, Wu T, Dai Y, Wang H, Wang W. Probiotic Escherichia coli Nissle 1917 Expressing Elafin Protects Against Inflammation and Restores the Gut Microbiota. Front Microbiol. 2022 May 6;13:819336. doi: 10.3389/fmicb.2022.819336. eCollection 2022.</citation>
      <PMID>35602072</PMID>
    </results_reference>
    <results_reference>
      <citation>Lahat A, Fidder HH, Ben-Horin S. Development and validation of a diverticular clinical score for symptomatic uncomplicated diverticular disease after acute diverticulitis in a prospective patient cohort. Therap Adv Gastroenterol. 2020 May 8;13:1756284820913210. doi: 10.1177/1756284820913210. eCollection 2020.</citation>
      <PMID>32523619</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 10, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
      <investigator_full_name>Erasmo Spaziani</investigator_full_name>
      <investigator_title>MD, PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diverticulitis</mesh_term>
      <mesh_term>Diverticulitis, Colonic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040515
  org study id: EcN2023
  nct id: NCT06040515
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to assess the efficacy and safety of the probiotic
        Escherichia coli Nissle 1917 (EcN®, Ca.Di.Group S.p.A) in the treatment of symptomatic
        patients after an episode of both complicated and uncomplicated acute colonic diverticulitis.
  
        The main question it aims to answer are:
  
          -  Is the studied probiotic able to significantly reduce symptoms, assessed by means of a
             validated and dedicated score?
  
          -  Is there any difference in microbiota among the study group at baseline and a selected
             cohort of patients subdivided in subjects with diverticulosis and asymptomatic subjects
             after an episode of acute uncomplicated diverticulitis or an episode of complicated
             diverticulitis submitted to surgery with colonic resection without stoma?
  
          -  Is there any difference in microbiota in the study group at baseline and after 3 and 6
             months of treatment with the probiotic?
  
          -  Is there any correlation between microbiota modification and symptoms during follow-up?
  
          -  Is there any impact on fecal calprotectin values before and during probiotic therapy?
  
          -  Is there any modification of evacuation before and during follow-up?
  
          -  Is probiotic able to prevent recurrent episodes of acute diverticulitis during
             follow-up?
  
          -  The safety of the probiotic will be assessed during the follow-up. The study group will
             be assessed at baseline and during follow-up with a dedicated clinical score and Bristol
             stool scale. Microbiota and fecal calprotectin values will be also assessed at baseline
             and during follow-up. Microbiota at baseline will be also evaluated for comparison in
             the three selected groups with diverticulosis and both asymptomatic and symptomatic
             after an episode of acute diverticulitis.
  observational model: Case-Only
  time perspective: Prospective
  measure: Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917
  time frame: Six-months follow-up
  description: Median symptomatic score assessed at baseline and during follow-up
  measure: Microbiota qualitative composition
  time frame: Baseline
  description: Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection.
  measure: Microbiota qualitative composition modification
  time frame: Baseline and during 6-month follow-up.
  description: Composition of microbiota will be assessed in symptomatic study groups with a dedicated kit for collection.
  measure: Microbiota qualitative composition and median symptomatic score correlation
  time frame: Baseline and during 6-month follow-up.
  description: Correlation between the median symptomatic score and qualitative composition of microbiota modification after therapy.
  measure: Concentration of fecal calprotectin
  time frame: Baseline and during 6-month follow-up.
  description: Assessment of fecal calprotectin concentration in the symptomatic study group.
  measure: Bristol stool scale modification
  time frame: Baseline and during 6-month follow-up.
  description: Assessment of median Bristol stool scale in the symptomatic study group.
  measure: Prevention of recurrent acute diverticulitis
  time frame: Six-month follow-up.
  description: Number off patients with recurrent acute diverticulitis.
  measure: Safety
  time frame: Six-month follow-up.
  description: Number of patients with adverse events.
  arm group label: Symptomatic patients after acute diverticulitis
  description: Patients aged ≥18 with persistent symptoms at least three months after a radiologic and/or endoscopic documented acute diverticulitis or after six months of surgery for complicated acute diverticulitis.
  Therapy with Escherichia coli Nissle 1917 (EcN®) will be prescribed for a global duration of six months with the following assumption schedule: 2 capsules b.i.d. during 4 weeks, followed by 1 capsule o.i.d during 20 days each month for 5 months.
  arm group label: Diverticulosis
  description: Patients with asymptomatic diverticulosis. No therapy will be administered. Microbiota assessment will be performed.
  arm group label: Asymptomatic patients after acute uncomplicated diverticulitis
  description: Asymptomatic patients assessed three months after an episode of acute uncomplicated diverticulitis. No therapy will be administered. Microbiota assessment will be performed.
  arm group label: Asymptomatic patients after acute complicated diverticulitis
  description: Asymptomatic patients assessed six months after an episode of acute complicated diverticulitis submitted to surgery with resection and without stoma . No therapy will be administered. Microbiota assessment will be performed.
  intervention type: Drug
  intervention name: Probiotic Formula
  description: Capsule with 25 billion live strains of Escherichia coli Nissle 1917
  arm group label: Symptomatic patients after acute diverticulitis
  other name: Escherichia coli Nissle 1917
  Stool
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Walter Elisei, MD
  role: Principal Investigator
  affiliation: • UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma
  last name: Antonio Tursi, MD, PhD
  phone: +393473490583
  email: antotursi@tiscali.it
  last name: Marcello Picchio, MD
  phone: +393392371293
  email: marcellopicchio@libero.it
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  citation: Kvasnovsky CL, Adams K, Papagrigoriadis S. Diverticular disease as a chronic gastrointestinal condition: experience from a specialist clinic. Eur J Gastroenterol Hepatol. 2015 Apr;27(4):442-8. doi: 10.1097/MEG.0000000000000304.
  PMID: 25874519
  citation: Mj O, Turner GA, A S, Frizelle FA, R P. Distinct changes in the colonic microbiome associated with acute diverticulitis. Colorectal Dis. 2022 Dec;24(12):1591-1601. doi: 10.1111/codi.16271. Epub 2022 Aug 11.
  PMID: 35950499
  citation: Tursi A, Papa V, Lopetuso LR, Settanni CR, Gasbarrini A, Papa A. Microbiota Composition in Diverticular Disease: Implications for Therapy. Int J Mol Sci. 2022 Nov 26;23(23):14799. doi: 10.3390/ijms232314799.
  PMID: 36499127
  citation: Teng G, Liu Z, Liu Y, Wu T, Dai Y, Wang H, Wang W. Probiotic Escherichia coli Nissle 1917 Expressing Elafin Protects Against Inflammation and Restores the Gut Microbiota. Front Microbiol. 2022 May 6;13:819336. doi: 10.3389/fmicb.2022.819336. eCollection 2022.
  PMID: 35602072
  citation: Lahat A, Fidder HH, Ben-Horin S. Development and validation of a diverticular clinical score for symptomatic uncomplicated diverticular disease after acute diverticulitis in a prospective patient cohort. Therap Adv Gastroenterol. 2020 May 8;13:1756284820913210. doi: 10.1177/1756284820913210. eCollection 2020.
  PMID: 32523619
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Roma La Sapienza
  investigator full name: Erasmo Spaziani
  investigator title: MD, PhD
  mesh term: Diverticulitis
  mesh term: Diverticulitis, Colonic
  sharing ipd: No