<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/NCT03793686</url>
  </required_header>
  <id_info>
    <org_study_id>18-CT-001</org_study_id>
    <nct_id>NCT03793686</nct_id>
  </id_info>
  <brief_title>A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea</brief_title>
  <official_title>A Phase 1 Double Blind, Randomized Clinical Study to Evaluate the Safety of Human Milk Oligosaccharides Following Antibiotic Therapy in Subjects With C. Difficile-associated Diarrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prolacta Bioscience</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prolacta Bioscience</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase I double blind, randomized clinical study to evaluate the safety of human milk&#xD;
      oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in&#xD;
      adults with Clostridium difficile-associated diarrhea (CDAD). Within 3 dose cohort, subjects&#xD;
      will be randomized in a 3:1 ratio to receive PBCLN-003 or placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to enroll subjects&#xD;
  </why_stopped>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Actual">September 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Characterization of Adverse Events in a dose escalation study of PBCLN-003</measure>
    <time_frame>Up to 8 Weeks</time_frame>
    <description>Comparison of adverse event reporting and grading results between groups using physical exams, safety related blood tests, and urinalysis, adverse event reports, and subject complaint logs.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Clostridium Difficile Diarrhea</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PBCLN-003, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PBCLN-003</intervention_name>
    <description>Investigational drug</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrollment episode of CDAD diagnosed based on &gt; 3 loose stools per day and detection&#xD;
             of CD toxin by nucleic acid amplification tests (NAAT), EIA or GDH&#xD;
&#xD;
          -  Mild to moderate CDAD during enrollment episode (per Society of Hospital&#xD;
             Epidemiologists of America (SHEA)/lnfectious Disease Society of America(ISDA)&#xD;
             criteria)&#xD;
&#xD;
          -  Current therapy with standard of care antibiotics for recurrent CDAD(vancomycin,&#xD;
             metronidazole, fidaxomicin)&#xD;
&#xD;
          -  BMI &gt; 18.5 and &lt; 40&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Agreement to adhere to the study protocol&#xD;
&#xD;
          -  Informed consent is obtained&#xD;
&#xD;
          -  Women who are capable of bearing children must have a negative pregnancy test at the&#xD;
             time of screening&#xD;
&#xD;
          -  Female subjects of childbearing potential must use birth control (defined as oral or&#xD;
             injectable contraceptives, intrauterine devices, surgical sterilization or a&#xD;
             combination of a condom and spermicide) during the study period and for up to 8 weeks&#xD;
             after the first drug of study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe CDAD during enrollment episode (per SHEA/ISDA criteria) characterized as&#xD;
             follows:&#xD;
&#xD;
               -  History of five (5) or more recurrences of CDAD within the past 12 months prior&#xD;
                  to potential study enrollment&#xD;
&#xD;
               -  History of fecal microbiome transplant or other microbiome directed experimental&#xD;
                  intervention for CDAD&#xD;
&#xD;
               -  History (ever) of CD complicating inflammatory bowel disease (Crohn's disease,&#xD;
                  ulcerative colitis), or history of bowel resection surgery (other than&#xD;
                  uncomplicated appendectomy) or history of other infectious diarrhea or diarrhea&#xD;
                  of unknown etiology since the initial episode of CDAD&#xD;
&#xD;
          -  Clinically immunocompromised due to any primary immune or autoimmune deficiency, as a&#xD;
             result of chronic disease, cancer or medication used to treat these diseases&#xD;
&#xD;
          -  Initiating a new diet or weight loss amounting to 10% within two weeks prior to date&#xD;
             of study entry&#xD;
&#xD;
          -  Enrolled in another clinical study for the therapy of CDAD or affecting nutritional&#xD;
             management during the study period&#xD;
&#xD;
          -  Enrolled or has been enrolled in another experimental (IND) study within two weeks&#xD;
             prior to date of study entry&#xD;
&#xD;
          -  Is pregnant or lactating&#xD;
&#xD;
          -  History of swallowing difficulties, including dysphagia or odynophagia for liquids or&#xD;
             solids&#xD;
&#xD;
          -  Use of any Probiotics (any formulation) within the two weeks prior to date of study&#xD;
             entry&#xD;
&#xD;
          -  New, or a change in the consumption of the following prescription medications or&#xD;
             over-the-counter (OTC) medications within two weeks prior to date of study entry:&#xD;
&#xD;
               -  Proton pump inhibitors (for example: Prilosec®, Nexium®)&#xD;
&#xD;
               -  Histamine-2 receptor antagonists (for example: Zantac®, Pepcid®)&#xD;
&#xD;
          -  Consumption of the following prescription medications during the current enrollment&#xD;
             episode: • Bezlotuxamab/Zinplava®&#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>David J Rechtman, MD</last_name>
    <role>Study Director</role>
    <affiliation>Vice President, Medical Affairs, Prolacta Bioscience</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Infectious Disease Specialist</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>October 13, 2020</last_update_submitted>
  <last_update_submitted_qc>October 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</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>Diarrhea</mesh_term>
  </condition_browse>
  <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/NCT03793686
org study id: 18-CT-001
nct id: NCT03793686
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This Phase I double blind, randomized clinical study to evaluate the safety of human milk
      oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in
      adults with Clostridium difficile-associated diarrhea (CDAD). Within 3 dose cohort, subjects
      will be randomized in a 3:1 ratio to receive PBCLN-003 or placebo.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Characterization of Adverse Events in a dose escalation study of PBCLN-003
time frame: Up to 8 Weeks
description: Comparison of adverse event reporting and grading results between groups using physical exams, safety related blood tests, and urinalysis, adverse event reports, and subject complaint logs.
arm group label: Experimental
arm group type: Experimental
description: PBCLN-003, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, daily in 3 divided oral doses for 7 days, 2 ascending dose cohorts
intervention type: Drug
intervention name: PBCLN-003
description: Investigational drug
arm group label: Experimental
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David J Rechtman, MD
role: Study Director
affiliation: Vice President, Medical Affairs, Prolacta Bioscience
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diarrhea
sharing ipd: No