[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603951":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":18,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":84,"whyStopped":18,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"elemental diet (ED)","EXPERIMENTAL","The intervention in this study will be an elemental diet (ED) formulation produced by mBIOTA. All patients randomized to the ED arm will receive a two-week supply (84 servings + additional packets as needed) of the \"original\" flavor mBIOTA elemental diet.",[13],"Dietary Supplement: elemental diet (ED)",{"label":15,"type":16,"description":17,"interventionNames":18},"control group","NO_INTERVENTION","Patients randomized to the control group will undergo counseling with a registered dietician for general dietary advice but will be instructed to continue their usual diet, as tolerated, without any restrictions.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DIETARY_SUPPLEMENT","mBIOTA is a palatable elemental diet formulation",[9],[25],"mBIOTA elemental diet",[27],{"name":28,"affiliation":5,"role":29},"Richard B Weinberg, MD","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Bradley Joseph, MD","CONTACT","703-463-1287","bradley.joseph@advocatehealth.org",{"name":28,"role":33,"phone":37,"phoneExt":18,"email":38},"704-355-2000","Richard.Weinberg@advocatehealth.org",[40],{"facility":5,"status":18,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Winston-Salem","North Carolina","27157","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-80.24422,36.09986,{"lat":50,"lon":49},[53,54],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":28,"role":33,"phone":37,"phoneExt":18,"email":38},{"type":56,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[58],{"name":59,"class":60},"mBIOTA","UNKNOWN","100603951","the-edict-trial---therapy-for-inflammatory-bowel-disease-flares-100603951",false,"NCT07143188","The EDICT Trial - Therapy for Inflammatory Bowel Disease Flares","Elemental Diet as an Adjunctive Therapy for Inflammatory Bowel Disease Flares The EDICT Trial","EDICT","Inclusion Criteria:\n\n* adults with an established diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease) who are being treated in the outpatient setting for an Inflammatory bowel disease (IBD) flare, defined as a clinically significant increase in IBD symptoms (e.g., abdominal pain, nausea, vomiting, diarrhea, joint pain, fever, bleeding, unintended weight loss).\n\nExclusion Criteria:\n\n* Patients requiring admission to the hospital for treatment of a flare\n* Patients with allergies to any ingredients in the mBIOTA Elemental Diet\n* Female patients who are pregnant\n* Patients with diabetes who are taking insulin as part of their treatment plan\n* Patients with other medical conditions or personal preferences that would compromise their ability to adhere to the elemental study","ALL","21 Years",{"count":72,"type":73},42,"ESTIMATED","INTERVENTIONAL",[76],"NA","Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC), are chronic inflammatory conditions of the gastrointestinal tract that affect millions of people in the United States of America. Among patients with IBD, symptomatic flares are quite common; up to 40-50% of patients in some populations report having a flare at least once per month. For most patients with IBD flares, the typical outpatient treatment consists of corticosteroids and, in some instances, initiation of or switching between 5-aminosalicylic acid-acid preparations, immunomodulators, or biologics. These treatments, while often effective, can have harmful side effects, especially when used for long durations of time. Therefore, alternative treatments are highly sought after by both patients and providers.",[79],"Inflammatory Bowel Disease",[81,82,83],"crohn's disease","ulcerative colitis","chronic gastrointestinal tract inflammation","NOT_YET_RECRUITING","2026-04-22",{"date":87,"type":88},"2026-04-23","ACTUAL",{"date":90,"type":73},"2026-08",{"date":92,"type":73},"2026-12",{"name":5,"class":6},1]