NCT06907498 Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults
| NCT ID | NCT06907498 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sheba Medical Center |
| Condition | Dientamoeba Fragilis Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-01-22 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Dafna Yahav, MD
PRINCIPAL INVESTIGATOR
Sheba Medical Center, Ramat-Gan, Israel
Frequently Asked Questions
Who can join the NCT06907498 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Dientamoeba Fragilis Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06907498 currently recruiting?
Yes, NCT06907498 is actively recruiting participants. Contact the research team at Nadav.Baharav@sheba.health.gov.il for enrollment information.
Where is the NCT06907498 trial being conducted?
This trial is being conducted at Ramat Gan, Israel.
Who is sponsoring the NCT06907498 clinical trial?
NCT06907498 is sponsored by Sheba Medical Center. The principal investigator is Dafna Yahav, MD at Sheba Medical Center, Ramat-Gan, Israel. The trial plans to enroll 60 participants.