Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults
ConditionDientamoeba Fragilis Infection
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Paromomycin
DrugParomomycin 500mg X3 / day
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ParomomycinExperimental treatment 1 intervention
Group B: MetronidazoleActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
clinical improvement or resolution
clinical improvement or resolution
Time frame
30 daySecondary outcomes
1
clinical improvement by a visual analogue scale
clinical improvement by a visual analogue scale
Time frame
30 day2
microbiological eradication
microbiological eradication - negative PCR
Time frame
30 day3
Quality of life scale
Quality of life scale
Time frame
30 day4
Adverse events
Adverse events - gastrointestinal, neurological
Time frame
30 daySponsors and contacts
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Source ClinicalTrials.gov