<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/NCT03251625</url>
  </required_header>
  <id_info>
    <org_study_id>No. BSMMU/2015/1011</org_study_id>
    <nct_id>NCT03251625</nct_id>
  </id_info>
  <brief_title>Multi-strain Probiotic in the Management of IBS-D</brief_title>
  <official_title>Supplementation With a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome - a Randomized, Double-blind, Placebo-controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. To assess the effect of multistrain probiotics on abdominal pain using a validated&#xD;
           symptom severity score in IBS patients.&#xD;
&#xD;
        2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for&#xD;
           IBS in a tertiary referral centre&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Accumulating evidence supports the view that an imbalance of gut bacteria&#xD;
      contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers&#xD;
      of pathogenic bacteria and help alleviate symptoms.&#xD;
&#xD;
      Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic&#xD;
      diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic&#xD;
      (Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or&#xD;
      placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary&#xD;
      outcome measure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <phase>Phase 4</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>a randomized, double-blind, placebo-controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Participants divided into two groups by randomization software, consisting of 200 in each group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo</measure>
    <time_frame>1 year.</time_frame>
    <description>The change in severity and frequency of abdominal pain as measured by IBS-Symptom Severity Scores during treatment with a multi-strain probiotic or placebo, and compared with baseline.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>To assess the effect of multistrain probiotics on abdominal</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>To assess the efficacy of a multistrain probiotic supplement</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Probiotic Formula Capsule</intervention_name>
    <arm_group_label>To assess the effect of multistrain probiotics on abdominal</arm_group_label>
    <arm_group_label>To assess the efficacy of a multistrain probiotic supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed case of IBS using Rome III criteria&#xD;
&#xD;
          2. Absence of red flag sign: anemia, fever, wt loss, per rectal bleeding, nocturnal&#xD;
             frequency, family history of inflammatory bowel disease (IBD), cancer&#xD;
&#xD;
          3. Age 18-55 years&#xD;
&#xD;
          4. No probiotics used in prior 3 months.&#xD;
&#xD;
          5. Agreed not to start any other drug unless clinically indicated.&#xD;
&#xD;
          6. No antibiotics in previous 2 months of enrolment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age&lt;18 or &gt;55 years&#xD;
&#xD;
          2. Previous treatment with probiotics within last 3 months&#xD;
&#xD;
          3. Pregnant or lactating females&#xD;
&#xD;
          4. Concurrent severe illness (Uncontrolled diabetes mellitus, Renal Dysfunction, Liver&#xD;
             disease, hyper and hypothyroidism)&#xD;
&#xD;
          5. Chronic organic bowel disorders e.g. inflammatory bowel diseases, tuberculosis,&#xD;
             Diverticular disease etc&#xD;
&#xD;
          6. Any previous gastrointestinal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ashton Harper, MRCS</last_name>
    <role>Study Director</role>
    <affiliation>Probiotics International Ltd (Protexin)</affiliation>
  </overall_official>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
    <investigator_full_name>S M khosruzzaman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>After completion of paper.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 2, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/25/NCT03251625/Prot_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/NCT03251625
org study id: No. BSMMU/2015/1011
nct id: NCT03251625
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
1. To assess the effect of multistrain probiotics on abdominal pain using a validated
           symptom severity score in IBS patients.

        2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for
           IBS in a tertiary referral centre
Background: Accumulating evidence supports the view that an imbalance of gut bacteria
      contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers
      of pathogenic bacteria and help alleviate symptoms.

      Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic
      diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic
      (Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or
      placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary
      outcome measure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: a randomized, double-blind, placebo-controlled clinical trial
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Participants divided into two groups by randomization software, consisting of 200 in each group.
measure: The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo
time frame: 1 year.
description: The change in severity and frequency of abdominal pain as measured by IBS-Symptom Severity Scores during treatment with a multi-strain probiotic or placebo, and compared with baseline.
arm group label: To assess the effect of multistrain probiotics on abdominal
arm group type: Placebo Comparator
description: To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.
arm group label: To assess the efficacy of a multistrain probiotic supplement
arm group type: Placebo Comparator
description: To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre
intervention type: Drug
intervention name: Probiotic Formula Capsule
arm group label: To assess the effect of multistrain probiotics on abdominal
arm group label: To assess the efficacy of a multistrain probiotic supplement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Ashton Harper, MRCS
role: Study Director
affiliation: Probiotics International Ltd (Protexin)
responsible party type: Principal Investigator
investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
investigator full name: S M khosruzzaman
investigator title: Principal Investigator
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
sharing ipd: Undecided
ipd description: After completion of paper.
provided document: 