<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/NCT02185092</url>
  </required_header>
  <id_info>
    <org_study_id>4258</org_study_id>
    <secondary_id>RSRCH032089</secondary_id>
    <nct_id>NCT02185092</nct_id>
  </id_info>
  <brief_title>Probiotic Use in Patients With Prior COPD Exacerbation</brief_title>
  <official_title>Probiotic Use in Patients With Prior COPD Exacerbation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine the hypothesis test that probiotics will reduce the&#xD;
      frequency of exacerbation in patients with COPD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lost funding&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2016</completion_date>
  <primary_completion_date type="Anticipated">October 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>COPD exacerbations</measure>
    <time_frame>1 year</time_frame>
    <description>The primary end point will be the number of COPD exacerbations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antibiotic Use</measure>
    <time_frame>1 year</time_frame>
    <description>Decreased oral or IV antibiotic use</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Systemic Steroid Use</measure>
    <time_frame>1 year</time_frame>
    <description>Decreased systemic steroid use</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COPD</condition>
  <condition>Obstructive Lung Disease</condition>
  <arm_group>
    <arm_group_label>Sugar Pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1 pill orally daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lactobacillus GG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 pill (2 x 10x 9 CFU) daily orally</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus GG</intervention_name>
    <description>probiotic supplement</description>
    <arm_group_label>Lactobacillus GG</arm_group_label>
    <other_name>Culturelle</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sugar pill</intervention_name>
    <description>placebo</description>
    <arm_group_label>Sugar Pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients admitted to OUMC or VAMC with a COPD exacerbation and pneumonia with&#xD;
             underlying COPD will be eligible and screened.&#xD;
&#xD;
          2. Patients seen in VA Chest Medicine clinic, OU Physicians clinic and Pulmonary fellows&#xD;
             clinic at PPOB who have had a COPD exacerbation within the last year.&#xD;
&#xD;
          3. Patients over age 18&#xD;
&#xD;
          4. Patients who have a pulmonary function test (PFT) showing COPD within 1 year of&#xD;
             enrollment in the study or if the treating physician plans to obtain PFT as part of&#xD;
             the patient's care plan.&#xD;
&#xD;
          5. Patients will be considered to have a diagnosis of COPD if they have a FEV1 of less&#xD;
             than 80% of predicted and a FVC/FEV1 ratio of less than 0.70 (as defined by GOLD&#xD;
             criteria).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with less than one year of life expectancy from a concomitant diagnosis&#xD;
&#xD;
          2. Any GI motility disorders or previous bowel resection surgery (short gut syndrome)&#xD;
&#xD;
          3. Any patients with decreased immune function or on medication that may decrease immune&#xD;
             function (other than low dose steroid or steroid taper).&#xD;
&#xD;
          4. Patients admitted within the last one year with a diagnosis of pancreatitis&#xD;
&#xD;
          5. Patients unable to give consent will not be included in the study.&#xD;
&#xD;
          6. Patients unable to sign consent&#xD;
&#xD;
          7. Patients already on azithromycin daily for COPD exacerbations&#xD;
&#xD;
          8. Patients under department of corrections custody.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen S Allen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OUHSC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OUHSC</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>May 19, 2017</last_update_submitted>
  <last_update_submitted_qc>May 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>exacerbations</keyword>
  <keyword>COPD</keyword>
  <keyword>pneumonia</keyword>
  <keyword>probiotic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</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/NCT02185092
org study id: 4258
secondary id: RSRCH032089
nct id: NCT02185092
lead sponsor: 
has dmc: Yes
The purpose of the study is to examine the hypothesis test that probiotics will reduce the
      frequency of exacerbation in patients with COPD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: COPD exacerbations
time frame: 1 year
description: The primary end point will be the number of COPD exacerbations.
measure: Antibiotic Use
time frame: 1 year
description: Decreased oral or IV antibiotic use
measure: Systemic Steroid Use
time frame: 1 year
description: Decreased systemic steroid use
arm group label: Sugar Pill
arm group type: Placebo Comparator
description: 1 pill orally daily
arm group label: Lactobacillus GG
arm group type: Active Comparator
description: 1 pill (2 x 10x 9 CFU) daily orally
intervention type: Dietary Supplement
intervention name: Lactobacillus GG
description: probiotic supplement
arm group label: Lactobacillus GG
other name: Culturelle
intervention type: Other
intervention name: Sugar pill
description: placebo
arm group label: Sugar Pill
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Karen S Allen, MD
role: Principal Investigator
affiliation: OUHSC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
sharing ipd: No