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/NCT05974657</url>
    </required_header>
    <id_info>
      <org_study_id>WK2023001</org_study_id>
      <nct_id>NCT05974657</nct_id>
    </id_info>
    <brief_title>Effectiveness and Safety of Lactobacillus Acidophilus LA85 in Preventing Antibiotic-Associated Diarrhea</brief_title>
    <official_title>Lactobacillus Acidophilus LA85 for Preventing Antibiotic-Associated Diarrhea: A Multi-Centric, Double-Blind, Randomized Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wecare Probiotics Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Methodex</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Wecare Probiotics Co., Ltd.</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 randomized, placebo-controlled, double-blind clinical trial aims to evaluate the&#xD;
        efficacy and safety of probiotics as food supplements in preventing antibiotic-associated&#xD;
        diarrhea. The study will involve 82 patients who will be randomly assigned to one of two&#xD;
        groups: an experimental group receiving a probiotic containing Lactobacillus acidophilus&#xD;
        LA85, and a placebo group. The primary outcomes measured include the number of days until the&#xD;
        onset of diarrhea, the duration of diarrhea (if it occurs), gastrointestinal quality of life&#xD;
        evaluation using the GIQLI questionnaire, and overall patient satisfaction.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomized, placebo-controlled, double-blind clinical trial aims to assess the&#xD;
        effectiveness and safety of probiotics as food supplements in preventing&#xD;
        antibiotic-associated diarrhea. The study will enroll 82 patients who will be randomly&#xD;
        assigned to either the experimental group or the placebo group. Participants in the&#xD;
        experimental group will receive a probiotic supplement containing Lactobacillus acidophilus&#xD;
        LA85, while those in the placebo group will receive a non-active substitute.&#xD;
  &#xD;
        The outcomes include the following measurements:&#xD;
  &#xD;
          1. Number of days until the onset of diarrhea.&#xD;
  &#xD;
          2. Duration of diarrhea, if it occurs.&#xD;
  &#xD;
          3. Evaluation of gastrointestinal quality of life using the GIQLI questionnaire.&#xD;
  &#xD;
          4. Overall patient satisfaction with the intervention. Throughout the trial, a double-blind&#xD;
             approach will be maintained, ensuring that both the participants and the investigators&#xD;
             are unaware of the treatment assignments. This helps minimize bias and ensures the&#xD;
             reliability of the results. To assess the efficacy and safety of probiotics, data will&#xD;
             be collected and analyzed using appropriate statistical methods. The number of days&#xD;
             until the onset of diarrhea will be compared between the two groups, as well as the&#xD;
             duration of diarrhea if it occurs. Gastrointestinal quality of life will be evaluated&#xD;
             using the GIQLI questionnaire, which measures various aspects related to&#xD;
             gastrointestinal well-being. Additionally, overall patient satisfaction with the&#xD;
             intervention will be assessed. By conducting this comprehensive clinical trial, we aim&#xD;
             to provide valuable insights into the potential benefits and safety of probiotics as&#xD;
             food supplements in preventing antibiotic-associated diarrhea. The results obtained will&#xD;
             contribute to evidence-based recommendations for healthcare professionals and may have&#xD;
             implications for improving patient outcomes and quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 31, 2021</start_date>
    <completion_date type="Actual">September 13, 2022</completion_date>
    <primary_completion_date type="Actual">August 3, 2022</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>Health Services Research</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Diarrhea Onset Time</measure>
      <time_frame>14 days</time_frame>
      <description>Evaluate stool characteristics on the Bristol Scale (Degree 5-7 indicative of diarrhea).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">82</enrollment>
    <condition>Antibiotic Side Effect</condition>
    <condition>Probiotics</condition>
    <condition>Diarrhea</condition>
    <arm_group>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Composition: 400mg maltodextrin (excipient)； Capsule total weight: 400mg； Primary conditioning: HPMC Capsules (Hydroxypropyl Methylcellulose)； Secondary conditioning：Cardboard case Secondary packaging content：14 capsules / blister, 1 blisters per case Dosage regimen: Take one capsule daily before meals； Storage：Store in a cool, dry place without exposure to the sun.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Probiotic group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Composition: 20mg (2x109 UFC/ capsule) Lactobacillus acidophilus LA85 (active principle) and 380mg maltodextrin (excipient)； Capsule total weight: 400mg； Primary conditioning: HPMC Capsules (Hydroxypropyl Methylcellulose)； Secondary conditioning：Cardboard case Secondary packaging content：14 capsules / blister, 1 blisters per case Dosage regimen: Take one capsule daily before meals； Storage：Store in a cool, dry place without exposure to the sun.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Probiotic Lactobacillus acidophilus LA85</intervention_name>
      <description>Through a randomized double-blind placebo-controlled method, the patients were randomly divided into placebo group and probiotic intervention group, and took probiotics once a day for 14 consecutive days.</description>
      <arm_group_label>Placebo group</arm_group_label>
      <arm_group_label>Probiotic group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients starting antibiotic treatment (Amoxicillin 750mg).&#xD;
  &#xD;
            -  Patients prone to diarrhea with the administration of Amoxicillin 750mg.&#xD;
  &#xD;
            -  Patients over 18 years of age.&#xD;
  &#xD;
            -  Patients of both sexes.&#xD;
  &#xD;
            -  Patients capable of understanding the clinical study and who are committed to&#xD;
               complying with the requirements and procedures of the study.&#xD;
  &#xD;
            -  Patients who have signed the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diabetic patients.&#xD;
  &#xD;
            -  Pregnant patients.&#xD;
  &#xD;
            -  Patients who are breastfeeding.&#xD;
  &#xD;
            -  Patients who require pharmacological treatment that triggers drug diarrhea (laxatives,&#xD;
               antacids with magnesium, chemotherapy, omeprazole, esomeprazole, lansoprazole,&#xD;
               rabeprazole, cimetidine ranitidine, mycophenolate nizatidine, ibuprofen, naproxen and&#xD;
               metformin).&#xD;
  &#xD;
            -  Patients requiring treatment with tricyclic antidepressants, antiepileptics,&#xD;
               antihistamines, antiparkinsons, antipsychotics, antispasmodics, verapamil, monoamine&#xD;
               oxidase inhibitors, opiates, sympathomimetics, antacids (with aluminum and calcium),&#xD;
               non-steroidal antidiarrheals and anti-inflammatory drugs.&#xD;
  &#xD;
            -  Patients who change the type of diet during the study.&#xD;
  &#xD;
            -  Patients with an allergy or intolerance to any of the ingredients in the formulation&#xD;
               of the product under study.&#xD;
  &#xD;
            -  Subjects with a history of drug, alcohol or other substance abuse, or other factors&#xD;
               that limit their ability to cooperate during the study.&#xD;
  &#xD;
            -  Subjects whose condition does not make them eligible for the study, according to the&#xD;
               investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joan Ciurana, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dentist Ciurana Clinic</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Xavier Calvo, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dentist Rob Clinic</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ciurana Clinic</name>
        <address>
          <city>Barcelona</city>
          <state>Castelldefels</state>
          <zip>08860</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>diarrhea</keyword>
    <keyword>probiotics</keyword>
    <keyword>Antibiotic Side Effect</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diarrhea</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/NCT05974657
  org study id: WK2023001
  nct id: NCT05974657
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This randomized, placebo-controlled, double-blind clinical trial aims to evaluate the
        efficacy and safety of probiotics as food supplements in preventing antibiotic-associated
        diarrhea. The study will involve 82 patients who will be randomly assigned to one of two
        groups: an experimental group receiving a probiotic containing Lactobacillus acidophilus
        LA85, and a placebo group. The primary outcomes measured include the number of days until the
        onset of diarrhea, the duration of diarrhea (if it occurs), gastrointestinal quality of life
        evaluation using the GIQLI questionnaire, and overall patient satisfaction.
  This randomized, placebo-controlled, double-blind clinical trial aims to assess the
        effectiveness and safety of probiotics as food supplements in preventing
        antibiotic-associated diarrhea. The study will enroll 82 patients who will be randomly
        assigned to either the experimental group or the placebo group. Participants in the
        experimental group will receive a probiotic supplement containing Lactobacillus acidophilus
        LA85, while those in the placebo group will receive a non-active substitute.
  
        The outcomes include the following measurements:
  
          1. Number of days until the onset of diarrhea.
  
          2. Duration of diarrhea, if it occurs.
  
          3. Evaluation of gastrointestinal quality of life using the GIQLI questionnaire.
  
          4. Overall patient satisfaction with the intervention. Throughout the trial, a double-blind
             approach will be maintained, ensuring that both the participants and the investigators
             are unaware of the treatment assignments. This helps minimize bias and ensures the
             reliability of the results. To assess the efficacy and safety of probiotics, data will
             be collected and analyzed using appropriate statistical methods. The number of days
             until the onset of diarrhea will be compared between the two groups, as well as the
             duration of diarrhea if it occurs. Gastrointestinal quality of life will be evaluated
             using the GIQLI questionnaire, which measures various aspects related to
             gastrointestinal well-being. Additionally, overall patient satisfaction with the
             intervention will be assessed. By conducting this comprehensive clinical trial, we aim
             to provide valuable insights into the potential benefits and safety of probiotics as
             food supplements in preventing antibiotic-associated diarrhea. The results obtained will
             contribute to evidence-based recommendations for healthcare professionals and may have
             implications for improving patient outcomes and quality of life.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: Double (Participant, Investigator)
  measure: Diarrhea Onset Time
  time frame: 14 days
  description: Evaluate stool characteristics on the Bristol Scale (Degree 5-7 indicative of diarrhea).
  arm group label: Placebo group
  arm group type: Placebo Comparator
  description: Composition: 400mg maltodextrin (excipient)； Capsule total weight: 400mg； Primary conditioning: HPMC Capsules (Hydroxypropyl Methylcellulose)； Secondary conditioning：Cardboard case Secondary packaging content：14 capsules / blister, 1 blisters per case Dosage regimen: Take one capsule daily before meals； Storage：Store in a cool, dry place without exposure to the sun.
  arm group label: Probiotic group
  arm group type: Active Comparator
  description: Composition: 20mg (2x109 UFC/ capsule) Lactobacillus acidophilus LA85 (active principle) and 380mg maltodextrin (excipient)； Capsule total weight: 400mg； Primary conditioning: HPMC Capsules (Hydroxypropyl Methylcellulose)； Secondary conditioning：Cardboard case Secondary packaging content：14 capsules / blister, 1 blisters per case Dosage regimen: Take one capsule daily before meals； Storage：Store in a cool, dry place without exposure to the sun.
  intervention type: Other
  intervention name: Probiotic Lactobacillus acidophilus LA85
  description: Through a randomized double-blind placebo-controlled method, the patients were randomly divided into placebo group and probiotic intervention group, and took probiotics once a day for 14 consecutive days.
  arm group label: Placebo group
  arm group label: Probiotic group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Joan Ciurana, Dr.
  role: Principal Investigator
  affiliation: Dentist Ciurana Clinic
  last name: Xavier Calvo, Dr.
  role: Principal Investigator
  affiliation: Dentist Rob Clinic
  facility: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Diarrhea
  sharing ipd: No