Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults

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)

NCT Number	NCT06907498
Lead Sponsor	Sheba Medical Center
Conditions	Dientamoeba Fragilis Infection
Enrollment	60 participants
Start Date	2024-01-22
Primary Completion	2026-06 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-02