🏛️ Verified NIH Record • Updated 2025-06-11

Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease (NCT03808103)

🔵 Active, Not Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Intralytix, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (22 items).

Location: Johns Hopkins Green Spring Station — Lutherville, Maryland

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Active Crohn's disease with a Harvey-Bradshaw Index (HBI) ≥ 4
  • Ongoing gastrointestinal pathology: colorectal tumor, gastrointestinal bleeding
  • Active malignancies or any malignant disease within the past 5 years
  • Indeterminate colitis, ulcerative colitis
  • Colectomy or partial colectomy (less than ileo-transverse colonic anastomosis).
  • Colonic or small bowel stoma
  • Active perianal lesions
  • Women who are pregnant or nursing, or plan to become pregnant during the study period
  • Severe uncontrolled diseases that could increase the risk for subjects participating in the study, including but not limited to: heart diseases, congestive heart failure, hypertension, lung diseases; endocrine diseases; clinically significant renal disease characterized by a glomerular filtration rate \< 60mL/min, hepatic diseases, haematological disorders, or other conditions that in the opinion of the Investigator could interfere with the interpretation of the study results.
  • Taking supplemental probiotics in the form of pills or tablets.
  • History or planned procedures specifically aimed at modifying the gastrointestinal microbiota within the past year.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

  • Johns Hopkins Green Spring Station — Lutherville, Maryland
  • Icahn School of Medicine at Mount Sinai Hospital — New York, New York

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗