[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568687":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":64,"collaborators":32,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":32,"eligibilityCriteria":72,"healthyVolunteers":69,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":32,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mirtazapine Group","EXPERIMENTAL","Subjects will present at Mayo Clinic through a doctor's appointment and a diagnosis of irritable bowel syndrome will be receiving mirtazapine by pill form.",[13],"Drug: Mirtazapine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","Subjects will present at Mayo Clinic through a doctor's appointment and a diagnosis of irritable bowel syndrome will be receiving placebo by pill form.",[19],"Other: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Mirtazapine","mirtazapine will be told to use 1 pill 1 hour before bedtime for the first week (7.5 mg po q.h.s.), 2 pills before bedtime during the second week of therapy (15 mg po q.h.s.), 3 pills (22.5 mg po q.h.s.) 1 hour before bedtime for the third week, and 4 pills (30 mg po q.h.s.) 1 hour prior to bedtime for the remainder of the study.",[9],[27],"Remeron",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Placebo will be told to use 1 pill 1 hour before bedtime for the first week (7.5 mg po q.h.s.), 2 pills before bedtime during the second week of therapy (15 mg po q.h.s.), 3 pills (22.5 mg po q.h.s.) 1 hour before bedtime for the third week, and 4 pills (30 mg po q.h.s.) 1 hour prior to bedtime for the remainder of the study.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Brian E Lacy, MD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Jessica C Petrov, MD","CONTACT","904-953-2000","Petrov.Jessica@mayo.edu",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Jacksonville","Florida","32224","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-81.65565,30.33218,{"lat":55,"lon":54},[58,62],{"name":59,"role":40,"phone":60,"phoneExt":32,"email":61},"Jessica C Petrov, M.D.","904-953-6970","researchparticipantadvocate@mayo.edu",{"name":63,"role":36,"phone":32,"phoneExt":32,"email":32},"Brian Lacy, M.D.",{"type":36,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Brian Lacy","Principal Investigator","100568687","early-phase-1-novel-pilot-study-to-treat-symptoms-of-ibs-with-diarrhea-using-combination-therapy-of-a-low-fodmap-diet-and-a-neuromodulator-100568687",false,"NCT06684470","Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator","Inclusion Criteria:\n\n* Participants must meet all of the inclusion criteria to participate in this study:\n\n  * Adults (ages 18-70)\n  * Score of \\>175 on the IBS-SSS questionnaire\n  * Must meet Rome IV criteria for IBS-D\n  * If subject is of reproductive capability a negative urine pregnancy test must be available prior to entering the study\n  * Ability to understand study procedures and to comply with them for the entire length of the study\n\nExclusion Criteria:\n\n* All candidates meeting any of the below exclusion criteria at baseline will be excluded from study participation:\n\n  * Score of \\\u003C 175 on the IBS-SSS\n  * Prior diagnoses of: known celiac disease, small intestinal bacterial overgrowth, inflammatory bowel disease, or microscopic colitis\n  * Ongoing significant anxiety or depression\n  * A history of a known side effect to mirtazapine\n  * Prior treatment with a low FODMAP diet or mirtazapine without clinical benefit\n  * Active alcohol or drug abuse\n  * Inability to read or understand the consent form\n  * Any other medical or psychological reason that would prevent active participation in a research study\n  * Pregnant females","ALL","18 Years","70 Years",{"count":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[81],"EARLY_PHASE1","The purpose of this research is to study the added benefit of treating IBS symptoms with a medication called mirtazapine in treating IBS symptoms when paired with a low-FODMAP diet compared to a low-FODMAP diet alone. FODMAP stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols. These are short-chain carbohydrates that can cause digestive distress in some people.\n\nYou have been asked to take part in this research because you have symptoms of diarrhea-predominant irritable bowel syndrome that may respond to treatment with a combination of a medication called mirtazapine and a low-FODMAP diet.",[84,85],"IBS - Irritable Bowel Syndrome","Diarrhea",[85,87,88],"IBS","Irritable Bowel Syndrome","2025-12-10",{"date":91,"type":92},"2025-12-18","ACTUAL",{"date":94,"type":92},"2024-12-19",{"date":96,"type":78},"2026-12-19",{"name":5,"class":6},1]