[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dientamoeba-fragilis-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dientamoeba-fragilis-infection":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100585832","paromomycin-or-metronidazole-for-symptomatic-dientamoeba-fragilis-in-adults-100585832",false,"NCT06907498","Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults","Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults (COMFORTER Trial) - Protocol for a Superiority Double Blind, Randomized Controlled Trial","COMFORTER","Inclusion Criteria:\n\nPatients over the age of 18, not including pregnant women - With persistent gastrointestinal symptoms (over one month).\n\n* Without any other clear diagnosis to explain these symptoms according to medical records.\n* With a positive PCR stool test for D. fragilis without any additional pathogen (patients with Blastocystis hominis in feces will not be excluded).\n\nExclusion Criteria:\n\n* Pregnancy\n* Hypersensitivity to any of the study drugs or to aminoglycosides\n* Patients age below 18 years\n* Metronidazole or paromomycin treatment in the last 3 months","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Dientameba Fragilis (D.fragilis) is a protozoan found in the digestive tract - in the human colon. there are disagreements regarding the preferred treatment for these cases, with several regimens tested in mostly small observational studies. Several drugs are currently recommended for D.fragilis, with metronidazole most commonly used. However, metronidazole therapy for treating dientamoebiasis in children was not associated with better clinical outcomes in a randomized, double-blinded and placebo-controlled clinical trial.\n\nHence, we aim to perform a double blind, randomized controlled trial, evaluating the clinical and microbiological efficacy of paromomycin versus metronidazole for the treatment of symptomatic adults with PCR positive dientamoeba fragilis.\n\nThe primary outcomes would be clinical improvement or resolution. Secondary outcomes include clinical improvement evaluated by a visual analogue scale; microbiological eradication, quality of life, and adverse events related to therapy.\n\nWe plan to include 60 patients (30 per arm)",[27],"Dientamoeba Fragilis Infection",[29,30,31,32,33],"Dientamoeba Fragilis","Diarrhea","Paromomycin","Metronidazole","Treatment","RECRUITING","2025-03-26",{"date":37,"type":38},"2025-04-02","ACTUAL",{"date":40,"type":38},"2024-01-22",{"date":42,"type":21},"2026-12",{"name":44,"class":45},"Sheba Medical Center","OTHER_GOV"]