{
  "FullStudy":{
    "Rank":217598,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519310",
          "OrgStudyIdInfo":{
            "OrgStudyId":"09-988"
          },
          "Organization":{
            "OrgFullName":"The Cleveland Clinic",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Gut Flora Dependent Metabolism of Dietary Phosphatidylcholine and Cardiovascular Disease",
          "OfficialTitle":"Gut Flora Dependent Metabolism of Dietary Phosphatidylcholine and Cardiovascular Disease",
          "Acronym":"Glory"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"April 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 23, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 1, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 3, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"The Cleveland Clinic",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). This study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt).",
          "DetailedDescription":"The purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). This study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt).\n\nMetabolism is a process that turns foods we eat into fuel for our bodies. Choline is nutrient found in a type of fat commonly found in foods. There is evidence that choline metabolism by bacteria in the intestines may be linked to cardiac risk.\n\nThe purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). This study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt).\n\nThis single center study will randomize 30 normal, healthy volunteers to 1 of 3 groups:\n\nGroup 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks. Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks.\n\nThe antibiotics to be used will be metronidazole (500 mg twice daily) and ciprofloxacin (500 mg daily) for one week. The probiotics to be used will be one serving size of standard flavored yogurt (approximately 170 g) twice daily for up to three weeks.\n\nStudy visits will occur at baseline, 1 week, and 4 weeks. Blood and urine samples will be collected at the start of each visit. Subjects will then eat 2 hard boiled eggs and be given a standard medical isotope. Additional blood samples will be obtained at 1, 2, 3, 4, and 6 hours, and a urine sample will be collected at 6 hours. Samples will be analyzed for choline levels, its byproducts, and isotope levels."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Nutrition"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "choline metabolism",
              "gut flora",
              "phosphatidylcholine",
              "lecithin"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Early Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Basic Science",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"4",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Group 1",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Group 1 (Antibiotics/probioitic):",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic"
                  ]
                }
              },{
                "ArmGroupLabel":"Group 2",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Group 2 (Antibiotics/no-probiotic):",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic"
                  ]
                }
              },{
                "ArmGroupLabel":"Group 3",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Group 3 (no-Antibiotics/probiotic):",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Antibiotic (metronidazole and ciprofloxacin)/probiotic"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Other",
                "InterventionName":"Antibiotic (metronidazole and ciprofloxacin)/probiotic",
                "InterventionDescription":"Antibiotic cocktail/yogurt as follows:\n\nGroup 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks. Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Group 1",
                    "Group 2",
                    "Group 3"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Primary Outcome",
                "PrimaryOutcomeDescription":"Phosphatidylcholine derived gut flora metabolites",
                "PrimaryOutcomeTimeFrame":"December 2016"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Secondary Outcome Measures",
                "SecondaryOutcomeDescription":"Cardiometabolic risk markers",
                "SecondaryOutcomeTimeFrame":"December 2016"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMen and women age 18 years or above.\nAble to provide informed consent and comply with study protocol\n\nExclusion Criteria:\n\nSignificant chronic illness or end-organ dysfunction, including known history of heart failure, renal failure, pulmonary disease, or hematologic diseases.\nActive infection or received antibiotics within 2 months of study enrollment\nUse of OTC probiotic within past 2 months, or ingestion of yogurt within past month\nChronic gastrointestinal disorders, or intolerance to probiotic therapy\nAllergies to eggs.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Cleveland Clinic",
                "LocationCity":"Cleveland",
                "LocationState":"Ohio",
                "LocationZip":"44195",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000000900",
                "InterventionMeshTerm":"Anti-Bacterial Agents"
              },{
                "InterventionMeshId":"D000008795",
                "InterventionMeshTerm":"Metronidazole"
              },{
                "InterventionMeshId":"D000002939",
                "InterventionMeshTerm":"Ciprofloxacin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000890",
                "InterventionAncestorTerm":"Anti-Infective Agents"
              },{
                "InterventionAncestorId":"D000000981",
                "InterventionAncestorTerm":"Antiprotozoal Agents"
              },{
                "InterventionAncestorId":"D000000977",
                "InterventionAncestorTerm":"Antiparasitic Agents"
              },{
                "InterventionAncestorId":"D000059005",
                "InterventionAncestorTerm":"Topoisomerase II Inhibitors"
              },{
                "InterventionAncestorId":"D000059003",
                "InterventionAncestorTerm":"Topoisomerase Inhibitors"
              },{
                "InterventionAncestorId":"D000004791",
                "InterventionAncestorTerm":"Enzyme Inhibitors"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000065609",
                "InterventionAncestorTerm":"Cytochrome P-450 CYP1A2 Inhibitors"
              },{
                "InterventionAncestorId":"D000065607",
                "InterventionAncestorTerm":"Cytochrome P-450 Enzyme Inhibitors"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M10350",
                "InterventionBrowseLeafName":"Metronidazole",
                "InterventionBrowseLeafAsFound":"Metronidazole",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2803",
                "InterventionBrowseLeafName":"Anti-Bacterial Agents",
                "InterventionBrowseLeafAsFound":"Antibiotic",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2805",
                "InterventionBrowseLeafName":"Antibiotics, Antitubercular",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M4759",
                "InterventionBrowseLeafName":"Ciprofloxacin",
                "InterventionBrowseLeafAsFound":"Ciprofloxacin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2795",
                "InterventionBrowseLeafName":"Anti-Infective Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2879",
                "InterventionBrowseLeafName":"Antiprotozoal Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2875",
                "InterventionBrowseLeafName":"Antiparasitic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M29124",
                "InterventionBrowseLeafName":"Cytochrome P-450 Enzyme Inhibitors",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infe",
                "InterventionBrowseBranchName":"Anti-Infective Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000002318",
                "ConditionMeshTerm":"Cardiovascular Diseases"
              }
            ]
          }
        }
      }
    }
  }
}