<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/NCT03829358</url>
  </required_header>
  <id_info>
    <org_study_id>SMART CITY #AID-497-A-1600004</org_study_id>
    <secondary_id>Sub Grant #IIE-00000078-UI-1</secondary_id>
    <nct_id>NCT03829358</nct_id>
  </id_info>
  <brief_title>The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation</brief_title>
  <official_title>The Role of Probiotics in Improving Quality of Life in Women With Functional Constipation: Randomized Double-blind Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fakultas Kedokteran Universitas Indonesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Agency for International Development (USAID)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Fakultas Kedokteran Universitas Indonesia</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>
      This study aimed to investigate the relationship between administration of probiotics and&#xD;
      improvement in quality of life in women with functional constipation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2018</start_date>
  <completion_date type="Actual">July 21, 2018</completion_date>
  <primary_completion_date type="Actual">July 21, 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in quality of life</measure>
    <time_frame>Three weeks after intervention.</time_frame>
    <description>Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction.&#xD;
Physical discomfort, minimum score 0, maximum score 16, lower value represents better outcome&#xD;
Psychosocial discomfort, minimum score 0, maximum score 32, lower value represents better outcome&#xD;
Worries/concerns, minimum score 0, maximum score 44, lower value represents better outcome&#xD;
Satisfaction, minimum score 0, maximum score 20, higher value represents better outcome&#xD;
Total score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction&#xD;
• Total score, minimum score -20, maximum score 92, lower value represents better outcome</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Constipation - Functional</condition>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lactobacillus plantarum IS-10506</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lactobacillus plantarum IS-10506</intervention_name>
    <description>Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.</description>
    <arm_group_label>Probiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Fermented milk containing placebo to be consumed once daily for three weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being declared healthy based on initial examination and the Structured Interview&#xD;
             Questionnaire (SIQ)&#xD;
&#xD;
          -  Having the symptoms and signs of functional constipation refer to ROME IV&#xD;
&#xD;
          -  Able to communicate well&#xD;
&#xD;
          -  Able to consume 1 bottle of fermented milk each day for three weeks&#xD;
&#xD;
          -  Not using antibiotic no later than one week before supplementation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with functional bowel disorder&#xD;
&#xD;
          -  Using anesthesia at least 4 weeks before treatment&#xD;
&#xD;
          -  Having a serious pathological disorder (carcinoma)&#xD;
&#xD;
          -  During healing phase of acute gastrointestinal disorders at least 4 weeks before&#xD;
             treatment&#xD;
&#xD;
          -  Having severe heart disease&#xD;
&#xD;
          -  Taking chronic medications such as antidepressants or analgesics&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hasan Maulahela, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fakultas Kedokteran Universitas Indonesia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Puskesmas Petamburan</name>
      <address>
        <city>Jakarta</city>
        <state>DKI Jakarta</state>
        <zip>11440</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 1, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>February 3, 2019</last_update_submitted>
  <last_update_submitted_qc>February 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fakultas Kedokteran Universitas Indonesia</investigator_affiliation>
    <investigator_full_name>Murdani Abdullah</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Constipation</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Probiotic</keyword>
  <keyword>PAC-QOL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03829358/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03829358
org study id: SMART CITY #AID-497-A-1600004
secondary id: Sub Grant #IIE-00000078-UI-1
nct id: NCT03829358
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aimed to investigate the relationship between administration of probiotics and
      improvement in quality of life in women with functional constipation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Improvement in quality of life
time frame: Three weeks after intervention.
description: Improvement in quality of life were assessed using PAC-QOL© (Patient Assessment of Constipation - Quality of Life) questionnaire, consisting of four domains: physical discomfort, psychosocial discomfort, worries/concerns, and satisfaction.
Physical discomfort, minimum score 0, maximum score 16, lower value represents better outcome
Psychosocial discomfort, minimum score 0, maximum score 32, lower value represents better outcome
Worries/concerns, minimum score 0, maximum score 44, lower value represents better outcome
Satisfaction, minimum score 0, maximum score 20, higher value represents better outcome
Total score = physical discomfort + psychosocial discomfort + worries/concerns - satisfaction
• Total score, minimum score -20, maximum score 92, lower value represents better outcome
arm group label: Probiotic
arm group type: Experimental
description: Lactobacillus plantarum IS-10506
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Lactobacillus plantarum IS-10506
description: Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.
arm group label: Probiotic
intervention type: Drug
intervention name: Placebo
description: Fermented milk containing placebo to be consumed once daily for three weeks.
arm group label: Placebo
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hasan Maulahela, MD
role: Principal Investigator
affiliation: Fakultas Kedokteran Universitas Indonesia
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Fakultas Kedokteran Universitas Indonesia
investigator full name: Murdani Abdullah
investigator title: Clinical Professor
mesh term: Constipation
provided document: 