Actively Recruiting
Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults
Led by Sheba Medical Center · Updated on 2025-04-02
60
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Persistent gastrointestinal symptoms lasting more than one month
- No other clear diagnosis explaining symptoms based on medical records
- Positive PCR stool test for Dientamoeba Fragilis without additional pathogens (presence of Blastocystis hominis allowed)
You will not qualify if you...
- Pregnancy
- Hypersensitivity to study drugs or aminoglycosides
- Age below 18 years
- Treatment with metronidazole or paromomycin within the last 3 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sheba medical center
Ramat Gan, Israel, Israel, 52621
Actively Recruiting
Research Team
N
Nadav Baharav, MD
CONTACT
S
Shlomit Romano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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