{
  "FullStudy":{
    "Rank":217735,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517516",
          "OrgStudyIdInfo":{
            "OrgStudyId":"11-000069"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"RO1 DKO48351",
                "SecondaryIdType":"Other Grant/Funding Number",
                "SecondaryIdDomain":"NIDDK"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"University of California, Los Angeles",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Multi Modal Imaging: An MRI Study to Investigate Differences in the Structure and the Function of the Brain at Rest.",
          "OfficialTitle":"A Magnetic Resonance Imaging (MRI) Study to Investigate Differences in the Structure and the Function of the Brain at Rest; Between Persons With Functional Pain Conditions Such as IBS or Vulvodynia, IBD and Healthy Controls",
          "Acronym":"MMI"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"March 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2015",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 14, 2011",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 12, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 14, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Emeran Mayer, MD",
            "ResponsiblePartyInvestigatorTitle":"Professor, Department of Medicine at the David Geffen School of Medicine, UCLA",
            "ResponsiblePartyInvestigatorAffiliation":"University of California, Los Angeles"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of California, Los Angeles",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)",
                "CollaboratorClass":"NIH"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The structural/RSN study involves Structural and Resting State Neuroimaging. The purpose of Structural Neuroimaging is to use MRI technology to identify cortical and white matter morphometric differences between patients with chronic pain conditions and healthy control subjects.\n\nThe purpose of the Resting State Neuroimaging study is to use functional MRI to identify possible disease related differences in various resting state networks in the brain.\n\nIn addition we are looking at the effect gut microbiota on brain function in healthy and IBS participants.\n\nThe overall goal is to identify structural and functional brain differences in persons with chronic pain conditions such as Irritable Bowel Syndrome (IBS, Cyclical Vomiting Syndrome(CVS) and vestibulodynia/vulvodynia. We are also looking at Inflammatory Bowel Disease(ulcerative colitis and Crohn's disease. We will be comparing differences between these conditions and matched healthy control subjects.",
          "DetailedDescription":"The study involves 2 visits. The screening visit is about 90 minutes and involves signing the consent, completing questionnaires, a medical history, modified physical exam and psychological interview to identify stressors, anxiety, depression and other conditions.\n\nThe second visit is the MRI visit (both functional and structural) and also will take about 90 minutes, with the scanning lasting about 45 minutes. There are questionnaires and a measure of skin conductance also.\n\nWe have added a single stool sample for microbiota analysis and a food frequency questionnaire in the healthy control and IBS populations."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Irritable Bowel Syndrome",
              "Cyclical Vomiting Syndrome",
              "Ulcerative Colitis",
              "Vulvodynia",
              "Crohn's Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "fMRI",
              "resting state",
              "structural MRI",
              "functional MRI"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "PatientRegistry":"No",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Case Control"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Cross-Sectional"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"165",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Functional Pain Conditions and Inflammatory bowel disease",
                "ArmGroupDescription":"Cyclical Vomiting Syndrome, Irritable Bowel Syndrome, Inflammatory Bowel disease (Ulcerative colitis and Crohns)and Vulvodynia (vestibulodynia)"
              },{
                "ArmGroupLabel":"Inflammatory Bowel Disease",
                "ArmGroupDescription":"Subjects diagnosed with Crohn's Disease or Ulcerative Colitis."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Resting state networks",
                "PrimaryOutcomeDescription":"The resting state functional MRI scan will be done to assess differences in the resting state networks in subjects with chronic pain conditions in comparison to healthy controls.",
                "PrimaryOutcomeTimeFrame":"within 1 week of scanning visit"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMen and women who meet the following criteria are eligible for inclusion in the study:\n\n18 to 55 years of age\nROME III criteria for IBS population\nWillingness to participate in this study as evidenced by a signed, written informed consent form (ICF).\nIf female and of childbearing potential willingness to avoid pregnancy and practice adequate birth control (abstinence, oral contraception, intrauterine devices, implantable devices, depot contraceptives, or barrier method with spermicide) during the time of study enrollment.\nIf female, negative urine pregnancy tests at Screening Visit 1, and visit 2.\nRight handed\nAmbulatory outpatient (not depending exclusively on a wheelchair for mobility)\nEnglish is primary oral and written language.\nDiagnosed with CVS\nDiagnosed with IBD and currently not taking steroid therapy.\nDiagnosed with vestibulodynia (a subgroup of vulvodynia)\nPre and peri menopausal only, post menopausal excluded.\n\nExclusion Criteria:\n\nEvidence of structural abnormality of the gastrointestinal tract. Subjects with Functional GI conditions must be without 'red flags', that may indicate gastrointestinal disease. Exclusionary GI conditions include but are not limited to: gastrointestinal surgery (exceptions: IBD group, appendectomy, benign polypectomy, cholecystectomy)also esophagitis, celiac disease, gastrointestinal malignancy or obstruction; peptic, duodenal or gastric ulcer disease.\nClinical evidence of cardiovascular, respiratory, renal, hepatic, malignancy, hematologic, neurologic, psychiatric or any disease that the PI determines may interfere with safe participation in the study\nUse of investigational drugs, products or devices within 28 days prior to screen and through study participation.\nSubjects with current regular use of narcotics and or opioids. Use of medications/drugs that affect the central nervous system. TCA's, SSRI's or other antidepressants are allowed if on stable dose for 3 months or more.\nPregnancy or breast feeding\nSubjects with extreme obesity (BMI > 35%)\nSubjects with metal implants, dental retainers, large tattoos (e.g. full arm or back) or claustrophobia; making MRI safety not possible.",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          },
          "StudyPopulation":"Subjects will be recruited from clinics, community in and around Los Angeles Area.",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Emeran Mayer, MD",
                "OverallOfficialAffiliation":"University of California, Los Angeles",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress",
                "LocationCity":"Los Angeles",
                "LocationState":"California",
                "LocationZip":"90095",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003424",
                "ConditionMeshTerm":"Crohn Disease"
              },{
                "ConditionMeshId":"D000003093",
                "ConditionMeshTerm":"Colitis, Ulcerative"
              },{
                "ConditionMeshId":"D000043183",
                "ConditionMeshTerm":"Irritable Bowel Syndrome"
              },{
                "ConditionMeshId":"D000056650",
                "ConditionMeshTerm":"Vulvodynia"
              },{
                "ConditionMeshId":"D000013577",
                "ConditionMeshTerm":"Syndrome"
              },{
                "ConditionMeshId":"D000014839",
                "ConditionMeshTerm":"Vomiting"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000004194",
                "ConditionAncestorTerm":"Disease"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000015212",
                "ConditionAncestorTerm":"Inflammatory Bowel Diseases"
              },{
                "ConditionAncestorId":"D000005759",
                "ConditionAncestorTerm":"Gastroenteritis"
              },{
                "ConditionAncestorId":"D000005767",
                "ConditionAncestorTerm":"Gastrointestinal Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000007410",
                "ConditionAncestorTerm":"Intestinal Diseases"
              },{
                "ConditionAncestorId":"D000003092",
                "ConditionAncestorTerm":"Colitis"
              },{
                "ConditionAncestorId":"D000003108",
                "ConditionAncestorTerm":"Colonic Diseases"
              },{
                "ConditionAncestorId":"D000012817",
                "ConditionAncestorTerm":"Signs and Symptoms, Digestive"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              },{
                "ConditionAncestorId":"D000003109",
                "ConditionAncestorTerm":"Colonic Diseases, Functional"
              },{
                "ConditionAncestorId":"D000014845",
                "ConditionAncestorTerm":"Vulvar Diseases"
              },{
                "ConditionAncestorId":"D000005831",
                "ConditionAncestorTerm":"Genital Diseases, Female"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M14938",
                "ConditionBrowseLeafName":"Syndrome",
                "ConditionBrowseLeafAsFound":"Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4903",
                "ConditionBrowseLeafName":"Colitis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4904",
                "ConditionBrowseLeafName":"Colitis, Ulcerative",
                "ConditionBrowseLeafAsFound":"Ulcerative Colitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15789",
                "ConditionBrowseLeafName":"Ulcer",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11649",
                "ConditionBrowseLeafName":"Pain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5221",
                "ConditionBrowseLeafName":"Crohn Disease",
                "ConditionBrowseLeafAsFound":"Crohn's Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M23705",
                "ConditionBrowseLeafName":"Irritable Bowel Syndrome",
                "ConditionBrowseLeafAsFound":"Irritable Bowel Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16165",
                "ConditionBrowseLeafName":"Vomiting",
                "ConditionBrowseLeafAsFound":"Vomiting",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M27116",
                "ConditionBrowseLeafName":"Vulvodynia",
                "ConditionBrowseLeafAsFound":"Vulvodynia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9027",
                "ConditionBrowseLeafName":"Intestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16500",
                "ConditionBrowseLeafName":"Inflammatory Bowel Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7458",
                "ConditionBrowseLeafName":"Gastroenteritis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4919",
                "ConditionBrowseLeafName":"Colonic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14205",
                "ConditionBrowseLeafName":"Signs and Symptoms, Digestive",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4920",
                "ConditionBrowseLeafName":"Colonic Diseases, Functional",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16171",
                "ConditionBrowseLeafName":"Vulvar Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7526",
                "ConditionBrowseLeafName":"Genital Diseases, Female",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              }
            ]
          }
        }
      }
    }
  }
}