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Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease

NCT03808103 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-15

No results posted yet for this study

Summary

This study will evaluate the safety of oral administration of EcoActive to patients with inactive Crohn's disease and how it affects the levels of AIEC in stool.

Conditions

  • Crohn Disease

Interventions

BIOLOGICAL

Placebo

Orally, twice a day, for a period of fifteen days

BIOLOGICAL

Bacteriophage preparation

Orally, twice a day, for a period of fifteen days

Sponsors & Collaborators

Principal Investigators

  • Robert Hirten, MD · Icahn School of Medicine at Mount Sinai

  • Reezwana Chowdhury, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2026-06-01
Completion
2026-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03808103 on ClinicalTrials.gov