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โ† Trials
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Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults

RecruitingNAAges 18 Years - anyAllSheba Medical Center
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In plain words

What the trial is, and whether it could suit you

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 v

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Patients over the age of 18, not including pregnant women - With persistent gastrointestinal symptoms (over one month). * 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). Exclusion Criteria: * 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
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What it tests

  • Paromomycin
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Where

1 site
Sheba medical center
Ramat Gan, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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