<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/NCT01728610</url>
  </required_header>
  <id_info>
    <org_study_id>IBS-2</org_study_id>
    <nct_id>NCT01728610</nct_id>
  </id_info>
  <brief_title>Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms</brief_title>
  <official_title>Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danisco</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Danisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyse the effect of a probiotic supplement on functional&#xD;
      intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the intervention is to analyse the effect of a probiotic supplement in a&#xD;
      dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS&#xD;
      according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life,&#xD;
      anxiety and depression and adequate relief will be assessed as with questionnaires as outcome&#xD;
      measures. The intestinal microbiota will be analysed from faecal samples.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in functional bowel symptoms</measure>
    <time_frame>0 weeks, 4 weeks, 12 weeks</time_frame>
    <description>Validated questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>0 weeks, 4 weeks, 12 weeks</time_frame>
    <description>Validated questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety and depression</measure>
    <time_frame>0 weeks, 4 weeks and 12 weeks</time_frame>
    <description>Validated questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adequate relief</measure>
    <time_frame>Weekly over 3 month intervention</time_frame>
    <description>Weekly question</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in faecal microbiota</measure>
    <time_frame>0 weeks, 4 weeks, 12 weeks</time_frame>
    <description>Detection and quantification of microbes from faecal samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of investigational product</measure>
    <time_frame>Throughout the intervention phase</time_frame>
    <description>Recording of adverse events and serious adverse events</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">391</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>Active high</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Probiotic, high dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active low</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Probiotic, low dose</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>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic (Active high)</intervention_name>
    <description>Higher dose of probiotic supplement</description>
    <arm_group_label>Active high</arm_group_label>
    <other_name>Lactobacillus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic (Active low)</intervention_name>
    <description>Lower dose of probiotic supplement</description>
    <arm_group_label>Active low</arm_group_label>
    <other_name>Lactobacillus</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Maltodextrin as placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 18 to 65 fulfilling Rome III criteria for IBS will be recruited.&#xD;
             Sufficient general health and orientation for participating in the study is required&#xD;
             and will be evaluated by the MDs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed or suspected organic gastrointestinal diseases or severely impaired general&#xD;
             health.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lea Veijola, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Herttoniemi Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arthur Ouwehand, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>DuPont Nutrition and Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sampo Lahtinen, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>DuPont Nutrition and Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna Lyra, PhD</last_name>
    <role>Study Director</role>
    <affiliation>DuPont Nutrition and Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mehiläinen Töölö</name>
      <address>
        <city>Helsinki</city>
        <zip>00260</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mehiläinen Turku</name>
      <address>
        <city>Turku</city>
        <zip>20100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>January 25, 2016</last_update_submitted>
  <last_update_submitted_qc>January 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>irritable bowel syndrome</keyword>
  <keyword>probiotic</keyword>
  <keyword>pain</keyword>
  <keyword>bloating</keyword>
  <keyword>diarrhoea</keyword>
  <keyword>constipation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</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/NCT01728610
org study id: IBS-2
nct id: NCT01728610
lead sponsor: 
has dmc: No
The purpose of this study is to analyse the effect of a probiotic supplement on functional
      intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).
The aim of the intervention is to analyse the effect of a probiotic supplement in a
      dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS
      according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life,
      anxiety and depression and adequate relief will be assessed as with questionnaires as outcome
      measures. The intestinal microbiota will be analysed from faecal samples.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in functional bowel symptoms
time frame: 0 weeks, 4 weeks, 12 weeks
description: Validated questionnaire
measure: Change in quality of life
time frame: 0 weeks, 4 weeks, 12 weeks
description: Validated questionnaire
measure: Change in anxiety and depression
time frame: 0 weeks, 4 weeks and 12 weeks
description: Validated questionnaire
measure: Adequate relief
time frame: Weekly over 3 month intervention
description: Weekly question
measure: Change in faecal microbiota
time frame: 0 weeks, 4 weeks, 12 weeks
description: Detection and quantification of microbes from faecal samples
measure: Safety of investigational product
time frame: Throughout the intervention phase
description: Recording of adverse events and serious adverse events
arm group label: Active high
arm group type: Active Comparator
description: Probiotic, high dose
arm group label: Active low
arm group type: Active Comparator
description: Probiotic, low dose
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Dietary Supplement
intervention name: Probiotic (Active high)
description: Higher dose of probiotic supplement
arm group label: Active high
other name: Lactobacillus
intervention type: Dietary Supplement
intervention name: Probiotic (Active low)
description: Lower dose of probiotic supplement
arm group label: Active low
other name: Lactobacillus
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Placebo
other name: Maltodextrin as placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lea Veijola, MD
role: Principal Investigator
affiliation: Herttoniemi Hospital
last name: Arthur Ouwehand, PhD
role: Study Chair
affiliation: DuPont Nutrition and Health
last name: Sampo Lahtinen, PhD
role: Study Chair
affiliation: DuPont Nutrition and Health
last name: Anna Lyra, PhD
role: Study Director
affiliation: DuPont Nutrition and Health
facility: 
facility: 
country: Finland
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
sharing ipd: No