<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/NCT04472065</url>
  </required_header>
  <id_info>
    <org_study_id>2020P000562</org_study_id>
    <nct_id>NCT04472065</nct_id>
  </id_info>
  <brief_title>Study of Probiotic Use After Childbirth in Relation to Emotional Well-Being</brief_title>
  <acronym>PACE</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of a Probiotic Dietary Supplement on the Gut Microbiome, Oxytocin Levels, Socio-emotional Functioning, and Well-being in Mother-Infant Dyads</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elizabeth Austen Lawson</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Researchers at Massachusetts General Hospital are interested in learning more about the&#xD;
      neurobiology of well-being in new mothers and novel ways to support them during their&#xD;
      transition to parenthood. This study aims to evaluate well-being in new mothers and their&#xD;
      infant and the impact of a probiotic dietary supplement on the gut microbiome. This study&#xD;
      hopes to help improve the existing knowledge of maternal postnatal health.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 10, 2021</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>
    <intervention_model_description>Expectant mothers who meet eligibility criteria will be randomized 1:1, stratified by C-section or vaginal delivery, to either the probiotic dietary supplement group or the placebo group and will be blinded to treatment assignment.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomization will be performed by the unblinded study pharmacist. All study staff will be blinded to treatment assignment. The infant will be assigned to the same group as their mother.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group</measure>
    <time_frame>6 week</time_frame>
    <description>Mother-infant bonding: Quantitative observational assessment of mother-infant bonding using the Child Interactive Behavior (CIB).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Toronto Alexithymia Scale (TAS-20) Total Score (range: 20-100; direction: lower scores indicate better socioemotional functioning) in the probiotic versus placebo group</measure>
    <time_frame>Baseline to Week 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group</measure>
    <time_frame>Baseline to Week 6</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Mental Health Wellness</condition>
  <arm_group>
    <arm_group_label>Subjects receiving Probiotic Dietary Supplement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects receiving Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lactobacillus reuteri</intervention_name>
    <description>1 chewable tablet of probiotic dietary supplement (200 million CFU of L. reuteri DSM 17938 and ATCC PTA 6475) consumed once per day orally for 6 weeks beginning at Baseline (between 1 to 3 days postpartum) to 6 weeks postpartum.</description>
    <arm_group_label>Subjects receiving Probiotic Dietary Supplement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1 chewable placebo tablet containing all the same ingredients except L. reuteri (DSM 17938 and ATCC PTA 6475) consumed once per day orally for 6 weeks beginning at Baseline (between 1 to 3 days postpartum) to 6 weeks postpartum.</description>
    <arm_group_label>Subjects receiving Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Able and willing to give written informed consent&#xD;
&#xD;
          2. Expectant mothers with singleton infant or mothers who have recently given birth to a&#xD;
             singleton infant&#xD;
&#xD;
          3. At least 18 years of age&#xD;
&#xD;
          4. At risk for postpartum depression as defined: a hx of depression and/or, a hx of&#xD;
             postpartum depression and/or by a prenatal EPDS score ≥ 8&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has active substance abuse in the past 6 months or a history of opioid use disorder&#xD;
&#xD;
          2. Has diabetes mellitus except for diet controlled gestational diabetes&#xD;
&#xD;
          3. Has uncontrolled thyroid disease&#xD;
&#xD;
          4. Has inflammatory gastrointestinal disease&#xD;
&#xD;
          5. Has active suicidal ideation&#xD;
&#xD;
          6. Has a history of psychosis&#xD;
&#xD;
          7. Has a history of an autism spectrum disorder&#xD;
&#xD;
          8. Plans to take other probiotics (other than study product) during study participation&#xD;
&#xD;
          9. Plans to take systemic hormonal contraception during study participation (Note:&#xD;
             intra-uterine device is allowed)&#xD;
&#xD;
         10. Is receiving any systemically administered immunosuppressant medication on a chronic&#xD;
             basis&#xD;
&#xD;
         11. Has a clinically significant or uncontrolled concomitant illness or condition that&#xD;
             would put the subject at risk or jeopardize the objectives of the study&#xD;
&#xD;
         12. Has a contraindication, sensitivity, or known allergy to any ingredient of the study&#xD;
             product&#xD;
&#xD;
         13. Is considered, in the opinion of the Principal Investigator (PI), to likely be a poor&#xD;
             attendee or unlikely for any reason to be able to comply with the study procedures&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth A Lawson, MD, MMSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Elizabeth Austen Lawson</investigator_full_name>
    <investigator_title>Elizabeth A. Lawson, M.D., M.M.Sc.</investigator_title>
  </responsible_party>
  <keyword>Gut microbiome</keyword>
  <keyword>Postpartum depression</keyword>
  <keyword>Oxytocin</keyword>
  <keyword>Socio-emotional functioning</keyword>
  <keyword>Probiotic</keyword>
  <!-- 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/NCT04472065
org study id: 2020P000562
nct id: NCT04472065
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Researchers at Massachusetts General Hospital are interested in learning more about the
      neurobiology of well-being in new mothers and novel ways to support them during their
      transition to parenthood. This study aims to evaluate well-being in new mothers and their
      infant and the impact of a probiotic dietary supplement on the gut microbiome. This study
      hopes to help improve the existing knowledge of maternal postnatal health.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Expectant mothers who meet eligibility criteria will be randomized 1:1, stratified by C-section or vaginal delivery, to either the probiotic dietary supplement group or the placebo group and will be blinded to treatment assignment.
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Randomization will be performed by the unblinded study pharmacist. All study staff will be blinded to treatment assignment. The infant will be assigned to the same group as their mother.
measure: Coding Interactive Behavior (CIB) Negative Scale Score (range: 1-5; direction: Higher values indicate worse maternal responses) in the probiotic versus placebo group
time frame: 6 week
description: Mother-infant bonding: Quantitative observational assessment of mother-infant bonding using the Child Interactive Behavior (CIB).
measure: Change in Toronto Alexithymia Scale (TAS-20) Total Score (range: 20-100; direction: lower scores indicate better socioemotional functioning) in the probiotic versus placebo group
time frame: Baseline to Week 6
measure: Change in relative abundance of microbial taxa (operational taxonomic units) in fecal samples in the probiotic versus placebo group
time frame: Baseline to Week 6
arm group label: Subjects receiving Probiotic Dietary Supplement
arm group type: Active Comparator
arm group label: Subjects receiving Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Lactobacillus reuteri
description: 1 chewable tablet of probiotic dietary supplement (200 million CFU of L. reuteri DSM 17938 and ATCC PTA 6475) consumed once per day orally for 6 weeks beginning at Baseline (between 1 to 3 days postpartum) to 6 weeks postpartum.
arm group label: Subjects receiving Probiotic Dietary Supplement
intervention type: Other
intervention name: Placebo
description: 1 chewable placebo tablet containing all the same ingredients except L. reuteri (DSM 17938 and ATCC PTA 6475) consumed once per day orally for 6 weeks beginning at Baseline (between 1 to 3 days postpartum) to 6 weeks postpartum.
arm group label: Subjects receiving Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth A Lawson, MD, MMSc
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Elizabeth Austen Lawson
investigator title: Elizabeth A. Lawson, M.D., M.M.Sc.