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Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults

Study acronym: COMFORTER
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 2, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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. Hence, 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. The 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. We plan to include 60 patients (30 per arm)
Trial Details
NCT Number NCT06907498
Lead Sponsor Sheba Medical Center
Conditions
(from sponsor)
Dientamoeba Fragilis Infection
Related terms Diarrhea, Dientamoebiasis
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov