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ACTIVE NOT RECRUITING Phase 1

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

NCT03808103 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Bacteriophage preparation

Study Locations (2)

Maryland

  • Johns Hopkins Green Spring Station — Lutherville

New York

  • Icahn School of Medicine at Mount Sinai Hospital — New York

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2019-05-01
Est. Completion 2026-06-01
Phase Phase 1

Sponsor

Intralytix

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03808103

The ClinicalTrials.gov registry entry for NCT03808103 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intralytix, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03808103 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Maryland, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03808103 about?

NCT03808103 is a clinical study titled "Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease". 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.

What is the current status of trial NCT03808103?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-05-01. Estimated completion is 2026-06-01.

What conditions does trial NCT03808103 study?

This clinical trial studies the following conditions: Crohn Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03808103?

The interventions under investigation include: Placebo (BIOLOGICAL), Bacteriophage preparation (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03808103?

This trial is sponsored by Intralytix, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03808103 being conducted?

This trial has 2 study locations across Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial