<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/NCT01731171</url>
  </required_header>
  <id_info>
    <org_study_id>SMRI/SPHS: 2012/1</org_study_id>
    <nct_id>NCT01731171</nct_id>
  </id_info>
  <brief_title>Probiotics to Prevent Relapse After Hospitalization for Mania</brief_title>
  <official_title>A Double-Blind Placebo-Controlled Trial of a Probiotic Supplement to Prevent Relapse and Improve the Clinical Course After Hospitalization for Mania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheppard Pratt Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanley Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheppard Pratt Health System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if taking a probiotic supplement versus a placebo&#xD;
      will lower rates of relapse and improve the clinical course among participants who have been&#xD;
      hospitalized for mania. Relapse and clinical course are measured by time to&#xD;
      re-hospitalizations, new mood episodes, and changes in mood-related symptoms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 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>Time to First Rehospitalization</measure>
    <time_frame>Weeks 0 - 24 of study participation</time_frame>
    <description>The primary outcome was the time to first psychiatric inpatient rehospitalization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Rehospitalized</measure>
    <time_frame>Weeks 0 - 24 of study participation</time_frame>
    <description>This is a count of the participants who had at least one rehospitalization during the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Number of Rehospitalizations</measure>
    <time_frame>Weeks 0 - 24 of study participation</time_frame>
    <description>This is a count of the number of rehospitalizations in each group during the study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Days Rehospitalized</measure>
    <time_frame>Weeks 0 - 24 of study participation</time_frame>
    <description>This is the mean number of days rehospitalized for participants in each group during the study period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Bipolar Disorder</condition>
  <condition>Schizoaffective Disorder</condition>
  <arm_group>
    <arm_group_label>Probiotic Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inert Compound</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic Supplement</intervention_name>
    <description>Probiotic Supplement 1 tablet by mouth daily</description>
    <arm_group_label>Probiotic Supplement</arm_group_label>
    <other_name>Probio-Tec</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Inert Compound</intervention_name>
    <description>Probiotic identical placebo 1 tablet by mouth daily</description>
    <arm_group_label>Inert Compound</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65&#xD;
&#xD;
          -  Capacity for written informed consent&#xD;
&#xD;
          -  Currently admitted to a Sheppard Pratt inpatient or day hospital for symptoms of mania&#xD;
&#xD;
          -  Primary Axis I diagnosis (DSM-IV) at time of admission of Bipolar I Disorder (single&#xD;
             manic episode, most recent episode manic, or most recent episode mixed) OR&#xD;
             Schizoaffective Disorder, Bipolar type (manic or mixed state)&#xD;
&#xD;
          -  Proficient in the English language&#xD;
&#xD;
          -  Available to come to Sheppard Pratt Towson for follow-up visits&#xD;
&#xD;
          -  Participated previously in one of our screening studies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of mental retardation&#xD;
&#xD;
          -  Symptoms of mania secondary to a general medical condition&#xD;
&#xD;
          -  Any clinically significant or unstable medical disorder as determined by the&#xD;
             investigators including congestive heart failure, abnormal liver function or disease,&#xD;
             renal failure, acute pancreatitis, any diagnosis of cancer undergoing active&#xD;
             treatment, HIV infection or other immunodeficiency condition&#xD;
&#xD;
          -  History of IV drug use&#xD;
&#xD;
          -  Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within&#xD;
             the last 3 months, or has a positive drug toxicity screen&#xD;
&#xD;
          -  Participated in any investigational drug trial in the past 30 days&#xD;
&#xD;
          -  Pregnant or planning to become pregnant during the study period&#xD;
&#xD;
          -  Receipt of antibiotic medication within the previous 24 hours (as anaerobic organisms&#xD;
             residing in the gastrointestinal tract may be minimally affected by antibiotics)&#xD;
&#xD;
          -  Documented celiac disease (as such persons should be on a gluten-free diet as this is&#xD;
             the standard care). Of note, we are not limiting the study to individuals with&#xD;
             elevated levels of gliadin or casein antibodies as we intend to look at these levels&#xD;
             as a predictor of response.&#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_official>
    <last_name>Faith Dickerson, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheppard Pratt Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheppard Pratt Health System</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21285</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>May 3, 2018</results_first_submitted>
  <results_first_submitted_qc>January 2, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 7, 2019</results_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheppard Pratt Health System</investigator_affiliation>
    <investigator_full_name>Faith Dickerson</investigator_full_name>
    <investigator_title>Head, Stanley Research Program</investigator_title>
  </responsible_party>
  <keyword>mania</keyword>
  <keyword>manic episode</keyword>
  <keyword>mixed episode</keyword>
  <keyword>bipolar disorder</keyword>
  <keyword>schizoaffective disorder</keyword>
  <keyword>probiotics</keyword>
  <keyword>probiotic supplement</keyword>
  <keyword>relapse prevention</keyword>
  <keyword>new mood episode</keyword>
  <keyword>re-hospitalization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Psychotic Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Probiotic Supplement</title>
          <description>The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.&#xD;
Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily</description>
        </group>
        <group group_id="P2">
          <title>Inert Compound</title>
          <description>The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.&#xD;
Inert Compound: Probiotic identical placebo 1 tablet by mouth daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved out of Area</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Terminated for Lack of Adherence</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Terminated for Safety Reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Probiotic Supplement</title>
          <description>The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.&#xD;
Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily</description>
        </group>
        <group group_id="B2">
          <title>Inert Compound</title>
          <description>The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.&#xD;
Inert Compound: Probiotic identical placebo 1 tablet by mouth daily</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="33"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.9" spread="11.7"/>
                    <measurement group_id="B2" value="33.3" spread="13.3"/>
                    <measurement group_id="B3" value="35.58" spread="12.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to First Rehospitalization</title>
        <description>The primary outcome was the time to first psychiatric inpatient rehospitalization.</description>
        <time_frame>Weeks 0 - 24 of study participation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Probiotic Supplement</title>
            <description>The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.&#xD;
Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Inert Compound</title>
            <description>The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.&#xD;
Inert Compound: Probiotic identical placebo 1 tablet by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Rehospitalization</title>
          <description>The primary outcome was the time to first psychiatric inpatient rehospitalization.</description>
          <units>Days to first readmission</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168" lower_limit="134" upper_limit="169"/>
                    <measurement group_id="O2" value="139" lower_limit="32" upper_limit="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>The effect of treatment was calculated using logistic regression and the Cox proportional hazard function employing age, gender, and race as covariates.</non_inferiority_desc>
            <p_value>=.029</p_value>
            <method>Regression, Logistic</method>
            <param_type>Cox Proportional Hazard</param_type>
            <param_value>0.37</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Values less than one favor adjunctive probiotic treatment, while values higher than one favor the placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Rehospitalized</title>
        <description>This is a count of the participants who had at least one rehospitalization during the study period.</description>
        <time_frame>Weeks 0 - 24 of study participation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Probiotic Supplement</title>
            <description>The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.&#xD;
Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Inert Compound</title>
            <description>The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.&#xD;
Inert Compound: Probiotic identical placebo 1 tablet by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Rehospitalized</title>
          <description>This is a count of the participants who had at least one rehospitalization during the study period.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=.022</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Number of Rehospitalizations</title>
        <description>This is a count of the number of rehospitalizations in each group during the study period.</description>
        <time_frame>Weeks 0 - 24 of study participation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Probiotic Supplement</title>
            <description>The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.&#xD;
Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Inert Compound</title>
            <description>The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.&#xD;
Inert Compound: Probiotic identical placebo 1 tablet by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Total Number of Rehospitalizations</title>
          <description>This is a count of the number of rehospitalizations in each group during the study period.</description>
          <units>rehospitalizations</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=.009</p_value>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Days Rehospitalized</title>
        <description>This is the mean number of days rehospitalized for participants in each group during the study period.</description>
        <time_frame>Weeks 0 - 24 of study participation</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Probiotic Supplement</title>
            <description>The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.&#xD;
Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily</description>
          </group>
          <group group_id="O2">
            <title>Inert Compound</title>
            <description>The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.&#xD;
Inert Compound: Probiotic identical placebo 1 tablet by mouth daily</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Days Rehospitalized</title>
          <description>This is the mean number of days rehospitalized for participants in each group during the study period.</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="6.3"/>
                    <measurement group_id="O2" value="8.3" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>=.017</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data are presented for the treatment phase (Weeks 0 - 24) of the trial.</time_frame>
      <desc>The occurrence of adverse events was assessed by asking participants about problems or health changes at all weekly phone calls and in-person study visits every four weeks throughout the 24-week treatment phase. Reported adverse events were categorized by organ system class.</desc>
      <group_list>
        <group group_id="E1">
          <title>Probiotic Supplement</title>
          <description>The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.&#xD;
Probiotic Supplement: Probiotic Supplement 1 tablet by mouth daily</description>
        </group>
        <group group_id="E2">
          <title>Inert Compound</title>
          <description>The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.&#xD;
Inert Compound: Probiotic identical placebo 1 tablet by mouth daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization after a fall</sub_title>
                <description>This single SAE was a hospitalization for a fall due to hyponatremia.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric rehospitalization</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E2" events="24" subjects_affected="17" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular Illness/Condition</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolic and/or Endocrine Illness/Condition</sub_title>
                <description>Although these are classified as metabolic and/or endocrine illness/condition in the trial, all AEs in this category fell under Endocrine.</description>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Illness/Condition</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dental Illness/Condition</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal Illness/Condition</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neurological or Sensory Illness/Condition</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Genitourinary Illness/Conition</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory Illness/Condition</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatological Illness/Condition</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Faith Dickerson</name_or_title>
      <organization>Sheppard Pratt Health System</organization>
      <phone>410-938-4359</phone>
      <email>fdickerson@sheppardpratt.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01731171
org study id: SMRI/SPHS: 2012/1
nct id: NCT01731171
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine if taking a probiotic supplement versus a placebo
      will lower rates of relapse and improve the clinical course among participants who have been
      hospitalized for mania. Relapse and clinical course are measured by time to
      re-hospitalizations, new mood episodes, and changes in mood-related symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Time to First Rehospitalization
time frame: Weeks 0 - 24 of study participation
description: The primary outcome was the time to first psychiatric inpatient rehospitalization.
measure: Number of Participants Rehospitalized
time frame: Weeks 0 - 24 of study participation
description: This is a count of the participants who had at least one rehospitalization during the study period.
measure: Total Number of Rehospitalizations
time frame: Weeks 0 - 24 of study participation
description: This is a count of the number of rehospitalizations in each group during the study period.
measure: Mean Days Rehospitalized
time frame: Weeks 0 - 24 of study participation
description: This is the mean number of days rehospitalized for participants in each group during the study period.
arm group label: Probiotic Supplement
arm group type: Experimental
description: The probiotic supplement compound will consist of capsules containing approximately 10^8 colony forming units of the probiotic organisms, LactobacillusGG and Bifidobacteria lactis strain Bb12. The capsule, which will be swallowed, is a size 3 opaque, hard, hypromellose capsule. The participant will be asked to take 1 capsule of the probiotic supplement with a meal or with a snack daily for 24 weeks.
arm group label: Inert Compound
arm group type: Placebo Comparator
description: The inert compound placebo looks identical to the probiotic supplement, and participants will be instructed to swallow 1 capsule with a meal or with a snack daily for 24 weeks.
intervention type: Dietary Supplement
intervention name: Probiotic Supplement
description: Probiotic Supplement 1 tablet by mouth daily
arm group label: Probiotic Supplement
other name: Probio-Tec
intervention type: Dietary Supplement
intervention name: Inert Compound
description: Probiotic identical placebo 1 tablet by mouth daily
arm group label: Inert Compound
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Faith Dickerson, PhD, MPH
role: Principal Investigator
affiliation: Sheppard Pratt Health System
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Sheppard Pratt Health System
investigator full name: Faith Dickerson
investigator title: Head, Stanley Research Program
mesh term: Recurrence
mesh term: Bipolar Disorder
mesh term: Psychotic Disorders
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 