<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/NCT03804736</url>
  </required_header>
  <id_info>
    <org_study_id>IF-0016-3</org_study_id>
    <nct_id>NCT03804736</nct_id>
  </id_info>
  <brief_title>Fecal Microbiota Transplant by Oral Capsules With Lactobacilli for Recurrent Clostridium Difficile Infection</brief_title>
  <official_title>Fecal Microbiota Transplant by Oral Capsules Enriched With Lactobacilli for Recurrent Clostridium Difficile Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Autonoma de Nuevo Leon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Autonoma de Nuevo Leon</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>
      Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral&#xD;
      capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile&#xD;
      recurrent infection&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators designed an open, two-arm study to compare to compare fecal microbiota&#xD;
      transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment&#xD;
      of C. difficile recurrent infection.&#xD;
&#xD;
      From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Fecal&#xD;
      samples are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic&#xD;
      sequencing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 1, 2016</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients were randomized by a closed envelope method in a 1: 1 ratio to either FMT-c (15 capsules every 12 h by 2 days) or a FMT-c and Lactobacillus (15 capsules every 12 h by 2 days)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>decrease in the number of evacuations</measure>
    <time_frame>up to two days</time_frame>
    <description>The cure of CDI was measured</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>FMT-c</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm received FMT-c (15 capsules every 12 h for 2 days)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FMT-c lactobacillus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm received FMT-c Lactobacillus (15 capsules every 12 h for 2 days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FMT-c</intervention_name>
    <description>Patients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)</description>
    <arm_group_label>FMT-c</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FMT-c Lactobacillus</intervention_name>
    <description>Patients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days)</description>
    <arm_group_label>FMT-c lactobacillus</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years With recurrent CDI&#xD;
&#xD;
        Exclusion Criteria:Older than 18 years&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>March 1, 2019</last_update_submitted>
  <last_update_submitted_qc>March 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Autonoma de Nuevo Leon</investigator_affiliation>
    <investigator_full_name>Adrián Camacho-Ortiz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>Clostridium Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT03804736
org study id: IF-0016-3
nct id: NCT03804736
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Investigators designed an open, two-arm study to compare fecal microbiota transplant by oral
      capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment of C. difficile
      recurrent infection
Investigators designed an open, two-arm study to compare to compare fecal microbiota
      transplant by oral capsules (FMT-c ) versus FMT-c enriched with Lactobacillus for treatment
      of C. difficile recurrent infection.

      From each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. Fecal
      samples are analyzed by 16 subunit ribosomal ribonucleic acid (16S rRNA) metagenomic
      sequencing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients were randomized by a closed envelope method in a 1: 1 ratio to either FMT-c (15 capsules every 12 h by 2 days) or a FMT-c and Lactobacillus (15 capsules every 12 h by 2 days)
measure: decrease in the number of evacuations
time frame: up to two days
description: The cure of CDI was measured
arm group label: FMT-c
arm group type: Active Comparator
description: Patients in this arm received FMT-c (15 capsules every 12 h for 2 days)
arm group label: FMT-c lactobacillus
arm group type: Experimental
description: Patients in this arm received FMT-c Lactobacillus (15 capsules every 12 h for 2 days)
intervention type: Biological
intervention name: FMT-c
description: Patients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)
arm group label: FMT-c
intervention type: Biological
intervention name: FMT-c Lactobacillus
description: Patients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days)
arm group label: FMT-c lactobacillus
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Universidad Autonoma de Nuevo Leon
investigator full name: Adrián Camacho-Ortiz
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections