Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults
Launched by SHEBA MEDICAL CENTER · Mar 26, 2025
Trial Information
Current as of June 06, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two different medications, paromomycin and metronidazole, to see which one works better for adults with a specific gut infection caused by a parasite called Dientamoeba fragilis. This infection can cause ongoing stomach problems, and while metronidazole is commonly used, previous studies have shown mixed results. The trial aims to compare how effective these two treatments are in improving symptoms and clearing the infection.
To participate, you need to be an adult over 18 years old, have had persistent stomach issues for more than a month, and have a positive stool test for D. fragilis without any other infections. Unfortunately, you cannot join if you are pregnant, allergic to the study medications, or have been treated with either medication in the past three months. If you join the study, you'll be randomly assigned to receive either paromomycin or metronidazole and will be monitored for improvements in your symptoms, quality of life, and any side effects from the treatment. The study is currently recruiting and aims to include 60 participants.
Gender
ALL
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
About Sheba Medical Center
Sheba Medical Center, located in Israel, is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, Sheba Medical Center leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes and developing novel therapeutic interventions. The center's collaborative environment fosters partnerships with global research organizations, enhancing its ability to contribute to the scientific community and drive medical advancements across various fields. With a strong focus on patient safety and ethical standards, Sheba Medical Center is dedicated to translating research findings into practical applications that benefit patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ramat Gan, , Israel
Patients applied
Trial Officials
Dafna Yahav, MD
Principal Investigator
Sheba Medical Center, Ramat-Gan, Israel
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported