[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655978":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":13,"armGroups":23,"interventions":35,"overallOfficials":13,"centralContacts":13,"locations":13,"responsibleParty":41,"collaborators":13,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":13,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":13,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":13,"overallStatus":65,"whyStopped":13,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":13},{"fullName":5,"class":6},"Tanta University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)","Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis). The Mayo Score ranges from 0 to 12, with higher scores indicating worse disease activity. Therefore, a decrease in score represents clinical improvement.","12 weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"DOUBLE",[21,22],"PARTICIPANT","INVESTIGATOR",[24,30],{"label":25,"type":26,"description":27,"interventionNames":28},"Arm 1","PLACEBO_COMPARATOR",": Placebo + Standard Therapy Standard ulcerative colitis therapy Placebo tablets twice daily fo",[29],"Drug: Nitazoxanide (NTZ)",{"label":31,"type":32,"description":33,"interventionNames":34},"Arm 2:","ACTIVE_COMPARATOR","Nitazoxanide + Standard Therapy Nitazoxanide 500 mg orally twice daily Standard ulcerative colitis therapy Duration: 12 weeks",[29],[36],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":13},"DRUG","Nitazoxanide (NTZ)","Nitazoxanide 500 mg orally twice daily",[25,31],{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Khadija Ahmed Mhrose Glal","Director","100655978","phase-2-nitazoxanide-as-adjunct-therapy-in-mild-to-moderate-ulcerative-colitis-100655978",false,"NCT07820046","Nitazoxanide as Adjunct Therapy in Mild-to-Moderate Ulcerative Colitis","Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria\n\n* Age 18-65 years\n* Confirmed ulcerative colitis ≥ 6 months\n* Mild-to-moderate active disease (Mayo score 3-10)\n* Stable UC therapy ≥ 8 weeks before enrollment Exclusion Criteria\n* Severe\u002Ffulminant UC requiring hospitalization or surgery\n* Active intestinal infection (e.g., C. difficile)\n* Antibiotics\u002Fprobiotics\u002Finvestigational drugs within 4 weeks\n* Recent biologic initiation or dose change\n* Severe hepatic, renal, cardiovascular disease, or malignancy\n* Pregnancy or lactation\n* Known hypersensitivity to nitazoxanide","ALL","18 Years","65 Years",{"count":56,"type":57},44,"ESTIMATED","INTERVENTIONAL",[60,61],"PHASE2","PHASE3","Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colonic mucosa. Despite advances in therapeutic options, many patients experience incomplete remission or treatment resistance. Emerging evidence suggests that intestinal barrier dysfunction, microbiota dysbiosis, and immune dysregulation play central roles in UC pathogenesis.\n\nNitazoxanide is a broad-spectrum antiparasitic agent with demonstrated antimicrobial, anti-inflammatory, and immunomodulatory effects, including inhibition of NF-κB signaling and improvement of intestinal barrier integrity. Preclinical studies suggest potential benefit in experimental colitis models; however, clinical evidence remains limited.\n\nThis randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of nitazoxanide as an adjunct to standard therapy in patients with mild-to-moderate ulcerative colitis over a 12-week treatment period.",[64],"Ulcerative Colitis (UC)","NOT_YET_RECRUITING","2026-09-09",{"date":68,"type":69},"2026-09-15","ACTUAL",{"date":71,"type":57},"2027-01-01",{"date":73,"type":57},"2028-01-01",{"name":5,"class":6}]