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/NCT06019312</url>
    </required_header>
    <id_info>
      <org_study_id>MUGdansk_Lp299v</org_study_id>
      <nct_id>NCT06019312</nct_id>
    </id_info>
    <brief_title>L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients</brief_title>
    <official_title>The Impact of Lactobacillus Plantarum 299v in Combination With Inulin on Gut Microbiome, Chemotherapy and Radiotherapy-induced Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients in Periooperative Period</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Gdansk</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Gdansk</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Colorectal cancer in periooperative period patients (n=60) will be enrolled to this study.&#xD;
        Participants will be divided into 4 groups as follows:&#xD;
  &#xD;
          -  group 1 (n=15) will receive 2 capsules (per day) of L. plantarum 299v L. plantarum 299v&#xD;
             (Sanprobi IBS®) for 4 weeks&#xD;
  &#xD;
          -  group 2 (n=15) will receive L. plantarum 299v (2 capsules per day) and inulin (4 g) for&#xD;
             4 weeks&#xD;
  &#xD;
          -  group 3 (n=15) will receive placebo (2 capsules per day) and inulin (4 g) for 4 weeks&#xD;
  &#xD;
          -  group 4 (n=15) will receive placebo (2 capsules per day) for 4 weeks&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>gut microbiota composition</measure>
      <time_frame>4 weeks</time_frame>
      <description>It will be measured by presenting alpha diversity and beta-diversity of microbial community and after that it will be presented using bioinformatic analysis.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>chemotherapy and radiotherapy-induced diarrhoea</measure>
      <time_frame>4 weeks</time_frame>
      <description>It will be analysed by using own created survey.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clostridioides difficile infection</measure>
      <time_frame>6 months</time_frame>
      <description>The incidence of Clostridioides difficile infection will be noted.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Colorectal Cancer</condition>
    <condition>Clostridioides Difficile Infection</condition>
    <condition>Diarrhea</condition>
    <arm_group>
      <arm_group_label>Lactobacillus plantarum 299v</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lactobacillus plantarum 299v in combination with inulin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v and inulin (4 g) for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo in combination with inulin</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>15 patients will receive 2 capsules (per day) of placebo for 4 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Sanprobi IBS®</intervention_name>
      <description>Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.</description>
      <arm_group_label>Lactobacillus plantarum 299v</arm_group_label>
      <arm_group_label>Lactobacillus plantarum 299v in combination with inulin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age ≥18 oraz ≤65&#xD;
  &#xD;
            -  patients with colorectal cancer prior to surgical treatment&#xD;
  &#xD;
            -  qualification to surgery&#xD;
  &#xD;
            -  the treatment with chemotherapy and radiotherapy in preoperative period&#xD;
  &#xD;
            -  an appropriate swallowing&#xD;
  &#xD;
            -  patients agreement to take part in this study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  the presence of other cancers than colorectal cancer&#xD;
  &#xD;
            -  inflammatory bowel diseases&#xD;
  &#xD;
            -  dysphagia&#xD;
  &#xD;
            -  intake of antibiotics, proton pump inhibitors, probiotics, and synbiotics 3 months&#xD;
               befor taking part in this study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Karolina Kaźmierczak-Siedlecka, PhD</last_name>
      <phone>607507240</phone>
      <email>leokadia@gumed.edu.pl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Unit of Surgery with Unit of Oncological Surgery in Koscierzyna</name>
        <address>
          <city>Kościerzyna</city>
          <zip>83-400</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Paweł Ulasiński</last_name>
        <phone>537168985</phone>
        <email>ulasinskipawel@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lactobacillus plantarum 299v</keyword>
    <keyword>Probiotics</keyword>
    <keyword>Colorectal Cancer</keyword>
    <keyword>Clostridioides difficile</keyword>
    <keyword>Diarrhea</keyword>
    <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>Clostridium Infections</mesh_term>
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Diarrhea</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06019312
  org study id: MUGdansk_Lp299v
  nct id: NCT06019312
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Colorectal cancer in periooperative period patients (n=60) will be enrolled to this study.
        Participants will be divided into 4 groups as follows:
  
          -  group 1 (n=15) will receive 2 capsules (per day) of L. plantarum 299v L. plantarum 299v
             (Sanprobi IBS®) for 4 weeks
  
          -  group 2 (n=15) will receive L. plantarum 299v (2 capsules per day) and inulin (4 g) for
             4 weeks
  
          -  group 3 (n=15) will receive placebo (2 capsules per day) and inulin (4 g) for 4 weeks
  
          -  group 4 (n=15) will receive placebo (2 capsules per day) for 4 weeks
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: gut microbiota composition
  time frame: 4 weeks
  description: It will be measured by presenting alpha diversity and beta-diversity of microbial community and after that it will be presented using bioinformatic analysis.
  measure: chemotherapy and radiotherapy-induced diarrhoea
  time frame: 4 weeks
  description: It will be analysed by using own created survey.
  measure: Clostridioides difficile infection
  time frame: 6 months
  description: The incidence of Clostridioides difficile infection will be noted.
  arm group label: Lactobacillus plantarum 299v
  arm group type: Experimental
  description: 15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v for 4 weeks
  arm group label: Lactobacillus plantarum 299v in combination with inulin
  arm group type: Experimental
  description: 15 patients will receive 2 capsules (per day - 1 capsule contains 10x10 CFU) of L. plantarum 299v and inulin (4 g) for 4 weeks
  arm group label: Placebo in combination with inulin
  arm group type: No Intervention
  description: 15 patients will receive 2 capsules (per day) of placebo and inulin (4 g) for 4 weeks
  arm group label: Placebo
  arm group type: No Intervention
  description: 15 patients will receive 2 capsules (per day) of placebo for 4 weeks
  intervention type: Dietary Supplement
  intervention name: Sanprobi IBS®
  description: Patients will be treated with probiotics in combination with inulin, which is able to stimulate the growing of probiotic bacteria in gastrointestinal tract.
  arm group label: Lactobacillus plantarum 299v
  arm group label: Lactobacillus plantarum 299v in combination with inulin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Karolina Kaźmierczak-Siedlecka, PhD
  phone: 607507240
  email: leokadia@gumed.edu.pl
  facility: 
  status: Recruiting
  contact: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Clostridium Infections
  mesh term: Colorectal Neoplasms
  mesh term: Diarrhea
  sharing ipd: Undecided