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Study identifier: NCT06907498 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults

Condition: Dientamoeba Fragilis Infection  ·  Sponsor: Sheba Medical Center

PhaseNA
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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)

This description comes directly from the study's public registry record.

Talk to the study team

Nadav Baharav, MD  ·  97235303500  ·  Nadav.Baharav@sheba.health.gov.il

Shlomit Romano  ·  Shlomit.Romano@sheba.health.gov.il

Always discuss trial participation with your own doctor first.

Locations (1)

Sheba medical centerRamat Gan, Israel, IsraelRecruiting

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Source record: clinicaltrials.gov/study/NCT06907498