Comparing Paromomycin and Metronidazole for Treating Dientamoeba Fragilis in Adults
Official title: Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults (COMFORTER Trial) - Protocol for a Superiority Double Blind, Randomized Controlled Trial
Run by Sheba Medical Center · NCT06907498 · Data updated 2026-11-12
This study tests whether the medication paromomycin works better than metronidazole for treating adults with gastrointestinal issues caused by Dientamoeba fragilis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Ramat Gan, Israel) |
| Status | Recruiting |
| Started | January 22, 2024 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | April 2, 2025 |
| Trial ID | NCT06907498 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 with persistent gastrointestinal symptoms and a positive PCR test for D. fragilis.
✕Probably not a fit
Patients who are pregnant, have hypersensitivity to the study drugs, or have received treatment with metronidazole or paromomycin in the last three months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of paromomycin versus metronidazole in treating symptomatic adults infected with Dientamoeba fragilis, a protozoan that can cause gastrointestinal issues. The study will be conducted as a double-blind, randomized controlled trial, focusing on clinical improvement and microbiological eradication as primary outcomes. Secondary outcomes will assess quality of life and any adverse events related to the treatments. Participants will be adults over 18 with persistent gastrointestinal symptoms and a positive PCR test for D. fragilis.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for adults suffering from Dientamoeba fragilis infections.
How similar studies have gone: While there have been observational studies on D. fragilis treatments, this trial's direct comparison of paromomycin and metronidazole is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Sheba medical center
Ramat Gan, Israel, Israel Recruiting
Study contacts
- Principal investigator: Dafna Yahav, MD — Sheba Medical Center, Ramat-Gan, Israel
- Study coordinator: Nadav Baharav, MD
- Email: Nadav.Baharav@sheba.health.gov.il
- Phone: 97235303500
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.