<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/NCT04414722</url>
  </required_header>
  <id_info>
    <org_study_id>2020-2431</org_study_id>
    <secondary_id>R33AT009622</secondary_id>
    <nct_id>NCT04414722</nct_id>
  </id_info>
  <brief_title>Mechanisms of Probiotics and Antibiotic-Associated Diarrhea</brief_title>
  <acronym>OURBIOTIC</acronym>
  <official_title>Exploratory Pilot Studies to Demonstrate Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The focus of the study is to better understand the mechanisms causing antibiotic-associated&#xD;
      diarrhea (AAD) and how probiotics may prevent some of the iatrogenic effects of antibiotic&#xD;
      medications. One of the most common indications for probiotics is for prevention of&#xD;
      antibiotic-associated diarrhea. Clinically, different probiotic strains have demonstrated the&#xD;
      ability to prevent AAD; however, the mechanism of action behind this effect has not been&#xD;
      elucidated. Data from several studies suggest that antibiotic-induced disruption of commensal&#xD;
      bacteria in the colon results in a significant (up to 50%) reduction in short chain fatty&#xD;
      acid (SCFA) production and a concomitant reduction in Na-dependent fluid absorption resulting&#xD;
      in AAD. Probiotics have been shown to ameliorate a variety of gastrointestinal disease states&#xD;
      and thus, the study investigators hypothesize that administration of a probiotic yogurt will&#xD;
      protect against the development of AAD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Probiotics are live microorganisms that, when administered in adequate amounts, confer a&#xD;
      health benefit on the host. One of the most common indications for probiotic treatment is the&#xD;
      prevention of antibiotic-associated diarrhea (AAD). Unfortunately, the efficacy of many&#xD;
      probiotic products used for AAD is not supported by rigorous independent research, and&#xD;
      non-evidence-based clinical usage is common. Data from several studies are consistent with&#xD;
      the notion that antibiotic-induced disruption of commensal bacteria in the colon results in a&#xD;
      significant reduction of short chain fatty acid (SCFA) production and a concomitant reduction&#xD;
      in Na-dependent fluid absorption resulting in AAD. The probiotic strain being studied,&#xD;
      Bifidobacterium animalis subsp. lactis BB-12 (BB-12), has been shown to ameliorate a variety&#xD;
      of gastrointestinal disease states and is known to produce acetate at concentrations up to 50&#xD;
      mM in vitro. Thus, the investigators hypothesize that administration of BB-12 at the same&#xD;
      time as antibiotic consumption will protect against the development of AAD through its&#xD;
      ability to generate acetate directly, and also increase other SCFAs through cross-feeding of&#xD;
      certain bacteria in the Firmicutes phylum such Clostridium, Eubacterium and Roseburia, which&#xD;
      use acetate to produce butyrate.&#xD;
&#xD;
      The primary aim is to determine the ability of BB-12 to impact antibiotic-induced reduction&#xD;
      in SCFA as reflected by the levels of acetate, the most abundant primary colonic SCFA, and&#xD;
      assess temporal intervals of probiotic administration. The primary hypothesis is that&#xD;
      antibiotics will result in a reduction in fecal SCFA, but BB-12 supplementation will protect&#xD;
      against antibiotic-induced SCFA reduction and/or be associated with a more rapid return to&#xD;
      baseline SCFA levels as compared to controls. Antibiotics also result in a decrease in total&#xD;
      microbial counts and diversity in the gut microbiota, disrupting the homeostasis of the gut&#xD;
      ecosystem and allowing colonization by pathogens. We hypothesize that concurrent&#xD;
      administration of the probiotic and antibiotic is not necessary for the probiotic impact on&#xD;
      SCFA.&#xD;
&#xD;
      The secondary aim will be to determine the ability of BB-12 to impact antibiotic-induced&#xD;
      disruption of the gut microbiota with 16S ribosomal ribonucleic acid (rRNA) profiling, and&#xD;
      assess temporal intervals of probiotic administration. The secondary hypothesis is that&#xD;
      antibiotics will result in a decrease in the overall number and diversity of bacterial&#xD;
      species present in the fecal microbiota, and further BB-12 supplementation will protect&#xD;
      against antibiotic-induced shifts in the microbiota and/or will be associated with a more&#xD;
      rapid return to a baseline microbiota composition as compared to controls. We hypothesize&#xD;
      that concurrent administration of the probiotic and antibiotic is not necessary for the&#xD;
      probiotic effect on the composition of the gut microbiota.&#xD;
&#xD;
      The tertiary aim is to longitudinally characterize the gut microbiota with high-throughput&#xD;
      metatranscriptomics in order to generate complementary information on the impact of&#xD;
      antibiotics plus and minus BB-12 on overall microbiome function. We hypothesize that acetate&#xD;
      produced by BB-12 in situ will cross-feed butyrate producers in the Firmicutes phylum&#xD;
      resulting in an up-regulation of butyrate biosynthetic pathways.&#xD;
&#xD;
      The long-term goal is to determine the impact of BB-12 on a variety of gastrointestinal&#xD;
      disease states and ages, through high-level independent research. This mechanism elucidation&#xD;
      is important for directing future translational and effectiveness research.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">May 1, 2023</completion_date>
  <primary_completion_date type="Actual">May 1, 2023</primary_completion_date>
  <phase>Early Phase 1</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)</measure>
    <time_frame>day 7</time_frame>
    <description>Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)</measure>
    <time_frame>day 30</time_frame>
    <description>Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in baseline diversity of bacterial species in fecal microbiota</measure>
    <time_frame>day 7, 14</time_frame>
    <description>Change in baseline diversity of bacterial species in fecal microbiota</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline number of bacterial species in fecal microbiota</measure>
    <time_frame>day 7, 14</time_frame>
    <description>Change in baseline number of bacterial species in fecal microbiota</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)</measure>
    <time_frame>day 14, 21</time_frame>
    <description>Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in reported symptoms: diarrhea/stool frequency, loose stool, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, allergic reaction, dyspepsia, and nausea.</measure>
    <time_frame>day 7, 14, 21, 30</time_frame>
    <description>Change in reported symptoms: diarrhea/stool frequency, loose stool, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, allergic reaction, dyspepsia, and nausea.</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">138</enrollment>
  <condition>Antibiotic-associated Diarrhea</condition>
  <arm_group>
    <arm_group_label>Concurrent control yogurt and amoxicillin-clavulanate</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control yogurt taken 4 hours after amoxicillin-clavulanate</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Concurrent BB-12 yogurt and amoxicillin-clavulanate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BB-12 yogurt taken 4 hours after amoxicillin-clavulanate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amoxicillin-clavulanate</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Amoxicillin-clavulanate 875 mg-125 mg oral tablet</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet</intervention_name>
    <description>Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet</description>
    <arm_group_label>Amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>BB-12 yogurt taken 4 hours after amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>Concurrent BB-12 yogurt and amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>Concurrent control yogurt and amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>Control yogurt taken 4 hours after amoxicillin-clavulanate</arm_group_label>
    <other_name>Augmentin</other_name>
    <other_name>Amoxicillin/clavulanic acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BB-12</intervention_name>
    <description>Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt</description>
    <arm_group_label>BB-12 yogurt taken 4 hours after amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>Concurrent BB-12 yogurt and amoxicillin-clavulanate</arm_group_label>
    <other_name>Bifidobacterium animalis subsp. lactis, BB-12</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Yogurt</intervention_name>
    <description>Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)</description>
    <arm_group_label>Concurrent control yogurt and amoxicillin-clavulanate</arm_group_label>
    <arm_group_label>Control yogurt taken 4 hours after amoxicillin-clavulanate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Has the ability to read, speak, and write in English&#xD;
&#xD;
          -  Has a refrigerator (for proper storage of the study yogurt)&#xD;
&#xD;
          -  Has reliable telephone access&#xD;
&#xD;
          -  Is between ages of 18-65 years&#xD;
&#xD;
          -  Agree to refrain from eating yogurts, yogurt drinks, and other foods specified in the&#xD;
             provided list&#xD;
&#xD;
          -  Agree to collect stool samples and participate in follow-up calls as specified&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes or asthma that requires medication&#xD;
&#xD;
          -  Allergy to strawberry&#xD;
&#xD;
          -  Active diarrhea (three or more loose stools per day for two consecutive days)&#xD;
&#xD;
          -  Any gastrointestinal (or digestive tract) medications, i.e. medicines for irritable&#xD;
             bowel syndrome, gastroesophageal (acid) reflux disease, inflammatory bowel disease,&#xD;
             etc.&#xD;
&#xD;
          -  History of heart disease, including valvulopathies or cardiac surgery, any implantable&#xD;
             device or prosthetic&#xD;
&#xD;
          -  History of gastrointestinal surgery or disease&#xD;
&#xD;
          -  Lactose intolerance that prevents participant from eating yogurt&#xD;
&#xD;
          -  Allergy to milk-protein&#xD;
&#xD;
          -  Allergy to any component of the product or the yogurt vehicle&#xD;
&#xD;
          -  Allergy to penicillin or cephalosporin class antibiotics&#xD;
&#xD;
          -  Allergy to any of the following medications: a) Penicillin; b) Erythromycin; c)&#xD;
             Tetracycline; d) Trimethoprim; e) Ciprofloxacin&#xD;
&#xD;
          -  Women who are breastfeeding, pregnant, or planning to become pregnant during the study&#xD;
&#xD;
          -  Was a participant in the &quot;YOBIOTIC&quot; study&#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>Daniel Merenstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgetown University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown University Department of Family Medicine</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 15, 2023</last_update_submitted>
  <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Georgetown University</investigator_affiliation>
    <investigator_full_name>Daniel Merenstein</investigator_full_name>
    <investigator_title>Director of Research Programs</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clavulanic Acid</mesh_term>
    <mesh_term>Clavulanic Acids</mesh_term>
    <mesh_term>Amoxicillin-Potassium Clavulanate Combination</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 13, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT04414722/ICF_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/NCT04414722
org study id: 2020-2431
secondary id: R33AT009622
nct id: NCT04414722
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The focus of the study is to better understand the mechanisms causing antibiotic-associated
      diarrhea (AAD) and how probiotics may prevent some of the iatrogenic effects of antibiotic
      medications. One of the most common indications for probiotics is for prevention of
      antibiotic-associated diarrhea. Clinically, different probiotic strains have demonstrated the
      ability to prevent AAD; however, the mechanism of action behind this effect has not been
      elucidated. Data from several studies suggest that antibiotic-induced disruption of commensal
      bacteria in the colon results in a significant (up to 50%) reduction in short chain fatty
      acid (SCFA) production and a concomitant reduction in Na-dependent fluid absorption resulting
      in AAD. Probiotics have been shown to ameliorate a variety of gastrointestinal disease states
      and thus, the study investigators hypothesize that administration of a probiotic yogurt will
      protect against the development of AAD.
Probiotics are live microorganisms that, when administered in adequate amounts, confer a
      health benefit on the host. One of the most common indications for probiotic treatment is the
      prevention of antibiotic-associated diarrhea (AAD). Unfortunately, the efficacy of many
      probiotic products used for AAD is not supported by rigorous independent research, and
      non-evidence-based clinical usage is common. Data from several studies are consistent with
      the notion that antibiotic-induced disruption of commensal bacteria in the colon results in a
      significant reduction of short chain fatty acid (SCFA) production and a concomitant reduction
      in Na-dependent fluid absorption resulting in AAD. The probiotic strain being studied,
      Bifidobacterium animalis subsp. lactis BB-12 (BB-12), has been shown to ameliorate a variety
      of gastrointestinal disease states and is known to produce acetate at concentrations up to 50
      mM in vitro. Thus, the investigators hypothesize that administration of BB-12 at the same
      time as antibiotic consumption will protect against the development of AAD through its
      ability to generate acetate directly, and also increase other SCFAs through cross-feeding of
      certain bacteria in the Firmicutes phylum such Clostridium, Eubacterium and Roseburia, which
      use acetate to produce butyrate.

      The primary aim is to determine the ability of BB-12 to impact antibiotic-induced reduction
      in SCFA as reflected by the levels of acetate, the most abundant primary colonic SCFA, and
      assess temporal intervals of probiotic administration. The primary hypothesis is that
      antibiotics will result in a reduction in fecal SCFA, but BB-12 supplementation will protect
      against antibiotic-induced SCFA reduction and/or be associated with a more rapid return to
      baseline SCFA levels as compared to controls. Antibiotics also result in a decrease in total
      microbial counts and diversity in the gut microbiota, disrupting the homeostasis of the gut
      ecosystem and allowing colonization by pathogens. We hypothesize that concurrent
      administration of the probiotic and antibiotic is not necessary for the probiotic impact on
      SCFA.

      The secondary aim will be to determine the ability of BB-12 to impact antibiotic-induced
      disruption of the gut microbiota with 16S ribosomal ribonucleic acid (rRNA) profiling, and
      assess temporal intervals of probiotic administration. The secondary hypothesis is that
      antibiotics will result in a decrease in the overall number and diversity of bacterial
      species present in the fecal microbiota, and further BB-12 supplementation will protect
      against antibiotic-induced shifts in the microbiota and/or will be associated with a more
      rapid return to a baseline microbiota composition as compared to controls. We hypothesize
      that concurrent administration of the probiotic and antibiotic is not necessary for the
      probiotic effect on the composition of the gut microbiota.

      The tertiary aim is to longitudinally characterize the gut microbiota with high-throughput
      metatranscriptomics in order to generate complementary information on the impact of
      antibiotics plus and minus BB-12 on overall microbiome function. We hypothesize that acetate
      produced by BB-12 in situ will cross-feed butyrate producers in the Firmicutes phylum
      resulting in an up-regulation of butyrate biosynthetic pathways.

      The long-term goal is to determine the impact of BB-12 on a variety of gastrointestinal
      disease states and ages, through high-level independent research. This mechanism elucidation
      is important for directing future translational and effectiveness research.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
time frame: day 7
description: Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
measure: Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
time frame: day 30
description: Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
measure: Change in baseline diversity of bacterial species in fecal microbiota
time frame: day 7, 14
description: Change in baseline diversity of bacterial species in fecal microbiota
measure: Change in baseline number of bacterial species in fecal microbiota
time frame: day 7, 14
description: Change in baseline number of bacterial species in fecal microbiota
measure: Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
time frame: day 14, 21
description: Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
measure: Change in reported symptoms: diarrhea/stool frequency, loose stool, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, allergic reaction, dyspepsia, and nausea.
time frame: day 7, 14, 21, 30
description: Change in reported symptoms: diarrhea/stool frequency, loose stool, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, allergic reaction, dyspepsia, and nausea.
arm group label: Concurrent control yogurt and amoxicillin-clavulanate
arm group type: Placebo Comparator
description: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
arm group label: Control yogurt taken 4 hours after amoxicillin-clavulanate
arm group type: Placebo Comparator
description: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12) taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
arm group label: Concurrent BB-12 yogurt and amoxicillin-clavulanate
arm group type: Active Comparator
description: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt and amoxicillin-clavulanate 875 mg-125 mg oral tablet, taken at the same time
arm group label: BB-12 yogurt taken 4 hours after amoxicillin-clavulanate
arm group type: Active Comparator
description: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt taken 4 hours after amoxicillin-clavulanate 875 mg-125 mg oral tablet
arm group label: Amoxicillin-clavulanate
arm group type: Other
description: Amoxicillin-clavulanate 875 mg-125 mg oral tablet
intervention type: Drug
intervention name: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
description: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
arm group label: Amoxicillin-clavulanate
arm group label: BB-12 yogurt taken 4 hours after amoxicillin-clavulanate
arm group label: Concurrent BB-12 yogurt and amoxicillin-clavulanate
arm group label: Concurrent control yogurt and amoxicillin-clavulanate
arm group label: Control yogurt taken 4 hours after amoxicillin-clavulanate
other name: Augmentin
other name: Amoxicillin/clavulanic acid
intervention type: Biological
intervention name: BB-12
description: Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
arm group label: BB-12 yogurt taken 4 hours after amoxicillin-clavulanate
arm group label: Concurrent BB-12 yogurt and amoxicillin-clavulanate
other name: Bifidobacterium animalis subsp. lactis, BB-12
intervention type: Other
intervention name: Control Yogurt
description: Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
arm group label: Concurrent control yogurt and amoxicillin-clavulanate
arm group label: Control yogurt taken 4 hours after amoxicillin-clavulanate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Merenstein, MD
role: Principal Investigator
affiliation: Georgetown University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Georgetown University
investigator full name: Daniel Merenstein
investigator title: Director of Research Programs
mesh term: Diarrhea
mesh term: Amoxicillin
mesh term: Clavulanic Acid
mesh term: Clavulanic Acids
mesh term: Amoxicillin-Potassium Clavulanate Combination
provided document: 