Paromomycin or Metronidazole for Symptomatic Dientamoeba Fragilis in Adults

NCT06907498 | Recruiting

• 1 other identifier: D. fragilis treatment
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Dientamoeba Fragilis Infection

Keywords

Dientamoeba Fragilis; Diarrhea; Paromomycin; Metronidazole; Treatment

Outcome Measures

Primary Outcomes (1)

• clinical improvement or resolution

  clinical improvement or resolution

  30 day

Secondary Outcomes (4)

• clinical improvement by a visual analogue scale

  30 day

• microbiological eradication

  30 day

• Quality of life scale

  30 day

• Adverse events

  30 day

Study Arms (2)

Paromomycin

EXPERIMENTAL

Paromomycin 500mg X3 / day

Drug: Paromomycin

Metronidazole

ACTIVE COMPARATOR

Metronidazole 500mg X3 / day

Drug: Paromomycin

Interventions

Paromomycin DRUG

Paromomycin 500mg X3 / day

Also known as: Kaman

Metronidazole; Paromomycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, Israel, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Dientamoebiasis; Diarrhea

Interventions

Paromomycin

Condition Hierarchy (Ancestors)

Intestinal Diseases, Parasitic; Parasitic Diseases; Infections; Protozoan Infections; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Dafna Yahav, MD

  Sheba Medical Center, Ramat-Gan, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadav Baharav, MD

CONTACT

97235303500; Nadav.Baharav@sheba.health.gov.il

Shlomit Romano

CONTACT

Shlomit.Romano@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Infectious Diseases Unit

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: April 2, 2025
• Study Start: January 22, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Within 90 days from study completion and for 1 year
• Access Criteria: By request from PI

Locations

IL (1)