xml: <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/NCT05990764</url>
    </required_header>
    <id_info>
      <org_study_id>03-AP-IBS</org_study_id>
      <nct_id>NCT05990764</nct_id>
    </id_info>
    <brief_title>Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)</brief_title>
    <official_title>Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AronPharma Sp. z o. o.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AronPharma Sp. z o. o.</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>
        The aim of the study is to demonstrate a beneficial effect in reducing symptoms that&#xD;
        negatively affect the quality of life of IBS patients, and to demonstrate a positive effect&#xD;
        on inflammatory and intestinal function markers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The double-blind, randomized, placebo-controlled study will be conducted on 48 patients&#xD;
        (18-55 years old) with Irritable Bowel Syndrome (IBS). The study will consist of 2 months of&#xD;
        supplementation with three parallel arms: 1) probiotic strains and prebiotic (Partially&#xD;
        Hydrolyzed Guar Gum); 2) probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and&#xD;
        elderberry and chokeberry fruit extract; 3) placebo.The study will assess symptoms associated&#xD;
        with IBS, using the IBS-QOL questionnaire and the Bristol Stool Formation Scale. Markers of&#xD;
        inflammation and intestinal barrier permeability , will be determined in blood and stool&#xD;
        samples collected from patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 8, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>IBS-QoL measures the impact of the disease on the quality of life of patients with IBS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Stool consistency</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Will be assessed using the Bristol Stool Chart</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Zonulin</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Zonulin level in stool samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short-chain fatty acids</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>Short-chain fatty acids level in stool samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IL-6</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>IL-6 level in serum samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IL-8</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>IL-8 level in serum samples</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>I-FABP</measure>
      <time_frame>Baseline, 2 months</time_frame>
      <description>I-FABP level in serum samples</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>IBS - Irritable Bowel Syndrome</condition>
    <arm_group>
      <arm_group_label>Probiotic, Prebiotic, Polyphenol-rich Extracts</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>18 patients with IBS</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Probiotic, Prebiotic</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>18 patients with IBS</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>18 patients with IBS</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Probiotic, Prebiotic, Polyphenol-rich Extracts</intervention_name>
      <description>probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract&#xD;
  Once a day</description>
      <arm_group_label>Probiotic, Prebiotic, Polyphenol-rich Extracts</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Probiotic, Prebiotic</intervention_name>
      <description>probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum)&#xD;
  Once a day</description>
      <arm_group_label>Probiotic, Prebiotic</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>placebo&#xD;
  Once a day</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed Irritable Bowel Syndrome.&#xD;
  &#xD;
            -  Women and men, 18-55 years old.&#xD;
  &#xD;
            -  Signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Intake of supplements containing plant extracts, polyphenols or anthocyanins, and&#xD;
               supplements containing fiber, probiotics and prebiotics.&#xD;
  &#xD;
            -  Participation in another clinical trial.&#xD;
  &#xD;
            -  Inability to swallow an oral study drug/placebo.&#xD;
  &#xD;
            -  Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis,&#xD;
               leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant and other&#xD;
               gastrointestinal diseases that may affect the results of the study.&#xD;
  &#xD;
            -  Women who are pregnant, planning to become pregnant during the study, or&#xD;
               breastfeeding,&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu</name>
        <address>
          <city>Poznań</city>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Barbara Khaidakov, PhD</last_name>
        <phone>798 210 651</phone>
        <phone_ext>+48</phone_ext>
        <email>barbara.khaidakov@aronpharma.pl</email>
      </contact>
      <investigator>
        <last_name>Dorota Mańkowska-Wierzbicka, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Liliana Łykowska-Szuber, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>IBS</keyword>
    <keyword>Gastrointestinal diseases</keyword>
    <keyword>Probiotic</keyword>
    <keyword>Prebiotic</keyword>
    <keyword>Plant extract</keyword>
    <keyword>Polyphenol-rich Extracts</keyword>
    <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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05990764
  org study id: 03-AP-IBS
  nct id: NCT05990764
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to demonstrate a beneficial effect in reducing symptoms that
        negatively affect the quality of life of IBS patients, and to demonstrate a positive effect
        on inflammatory and intestinal function markers.
  The double-blind, randomized, placebo-controlled study will be conducted on 48 patients
        (18-55 years old) with Irritable Bowel Syndrome (IBS). The study will consist of 2 months of
        supplementation with three parallel arms: 1) probiotic strains and prebiotic (Partially
        Hydrolyzed Guar Gum); 2) probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and
        elderberry and chokeberry fruit extract; 3) placebo.The study will assess symptoms associated
        with IBS, using the IBS-QOL questionnaire and the Bristol Stool Formation Scale. Markers of
        inflammation and intestinal barrier permeability , will be determined in blood and stool
        samples collected from patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Double (Participant, Investigator)
  measure: IBS-QoL (Irritable Bowel Syndrome-Quality of Life) index
  time frame: Baseline, 2 months
  description: IBS-QoL measures the impact of the disease on the quality of life of patients with IBS
  measure: Stool consistency
  time frame: Baseline, 2 months
  description: Will be assessed using the Bristol Stool Chart
  measure: Zonulin
  time frame: Baseline, 2 months
  description: Zonulin level in stool samples
  measure: Short-chain fatty acids
  time frame: Baseline, 2 months
  description: Short-chain fatty acids level in stool samples
  measure: IL-6
  time frame: Baseline, 2 months
  description: IL-6 level in serum samples
  measure: IL-8
  time frame: Baseline, 2 months
  description: IL-8 level in serum samples
  measure: I-FABP
  time frame: Baseline, 2 months
  description: I-FABP level in serum samples
  arm group label: Probiotic, Prebiotic, Polyphenol-rich Extracts
  arm group type: Experimental
  description: 18 patients with IBS
  arm group label: Probiotic, Prebiotic
  arm group type: Experimental
  description: 18 patients with IBS
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: 18 patients with IBS
  intervention type: Dietary Supplement
  intervention name: Probiotic, Prebiotic, Polyphenol-rich Extracts
  description: probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum) and elderberry and chokeberry extract
  Once a day
  arm group label: Probiotic, Prebiotic, Polyphenol-rich Extracts
  intervention type: Dietary Supplement
  intervention name: Probiotic, Prebiotic
  description: probiotic strains, prebiotic (Partially Hydrolyzed Guar Gum)
  Once a day
  arm group label: Probiotic, Prebiotic
  intervention type: Other
  intervention name: Placebo
  description: placebo
  Once a day
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Irritable Bowel Syndrome
  mesh term: Syndrome
  sharing ipd: No