Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheba Medical Center

About this trial

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)

Eligibility criteria

Qualifiers

Without any other clear diagnosis to explain these symptoms according to medical records.

With a positive PCR stool test for D. fragilis without any additional pathogen (patients with Blastocystis hominis in feces will not be excluded).

Disqualifiers

Pregnancy

Hypersensitivity to any of the study drugs or to aminoglycosides

Patients age below 18 years

Metronidazole or paromomycin treatment in the last 3 months

Trial design

Treatments tested in this trial

  • Paromomycin

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators