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

June 11, 2025 updated by: Intralytix, Inc.

A Phase 1/2a Double-Blind, Randomized, Placebo-Controlled Trial to Assess the Safety and Efficacy of Oral Administration of EcoActive on Intestinal Adherent Invasive Escherichia Coli (AIEC) in Patients With Inactive Crohn's Disease (CD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to determine if EcoActive is safe and effective in people with Crohn's disease. EcoActive is a collection of bacteriophages. Bacteriophages (or phages) are viruses that infect only bacteria. The phages in EcoActive infect a specific type of bacteria called Adherent Invasive Escherichia coli (AIEC).

The cause of Crohn's disease is poorly understood. However, the presence of AIEC in the intestines is associated with worsening inflammation in this disease. Inflammation is the presence of redness, irritation, and ulcers in the intestines. By using phages that only infect and kill this specific type of bacteria (AIEC), it is the hope this can be used to improve the course of Crohn's disease. The phages would only target the AIEC, without affecting the natural, often helpful, bacteria of the intestines. EcoActive may also lessen the use of antibiotics to control symptoms. When antibiotics are used, they can have major effects on the rest of the bacteria in the intestines. Also, repeated use can cause intestinal bacteria to become resistant to antibiotics. Reduced use of antibiotics would limit both of these risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins Green Spring Station
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female ≥ 18 years of age
  2. Inactive Crohn's disease in clinical and objective remission with a Harvey-Bradshaw Index (HBI) < 4
  3. Permitted CD medications expected to remain stable during the period of the study (see Section 7 "Concomitant Crohn's Disease Medications" for allowed and prohibited drugs).
  4. Crohn's disease history ≥ 6-month duration
  5. CRP (C-reactive protein) within normal range at the Screening visit (based on normal range of the local laboratory)
  6. Fecal calprotectin level ≤ 150 µg/g at the Screening visit
  7. AIEC detected in the stool
  8. Females of childbearing age must be using an effective method of contraception to prevent pregnancy and agree to continue to practice an acceptable method of contraception for the duration of participation in the study (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).
  9. Negative pregnancy test for women of childbearing age (menarche to menopause)
  10. Patient understands the study procedures, and can sign the informed consent, and the authorization to release relevant protected health information to the Study Investigator.

Exclusion Criteria:

  1. Active Crohn's disease with a Harvey-Bradshaw Index (HBI) ≥ 4
  2. Ongoing gastrointestinal pathology: colorectal tumor, gastrointestinal bleeding
  3. Active malignancies or any malignant disease within the past 5 years
  4. Indeterminate colitis, ulcerative colitis
  5. Colectomy or partial colectomy (less than ileo-transverse colonic anastomosis).
  6. Colonic or small bowel stoma
  7. Active perianal lesions
  8. Women who are pregnant or nursing, or plan to become pregnant during the study period
  9. 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.
  10. Taking supplemental probiotics in the form of pills or tablets.
  11. History or planned procedures specifically aimed at modifying the gastrointestinal microbiota within the past year.
  12. Topical gastrointestinal treatment (e.g., enemas) in the 2 weeks prior to the Screening visit or planned during the study period
  13. Use of bowel cleansing or preparation for endoscopy, TDM or MRI in the 4 weeks prior to the Screening visit or planned during the study period.
  14. Receipt of antibiotics 4 weeks before the Screening visit or planned during the study period.
  15. Known allergy or hypersensitivity to an excipient in the study drug or placebo
  16. Psychological or linguistic incapability to sign the informed consent.
  17. Lack or expected lack of cooperation or compliance with the study.
  18. Receipt of mesalamine based therapies within 4 weeks of the screening visit.
  19. Severe psychiatric, psychological, or neurological disorders.
  20. Alcohol, drug or medication abuse within the past year.
  21. Subject who cannot be contacted in case of emergency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Dose is 1mL of placebo given orally twice a day for 15 days
Biological: Placebo
Orally, twice a day, for a period of fifteen days
Other Names:
  • 0.9% saline
Experimental: Phage
Dose is 1mL of bacteriophage preparation given orally twice a day for 15 days
Biological: Bacteriophage preparation
Orally, twice a day, for a period of fifteen days
Other Names:
  • EcoActive

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 6 months
The number of solicited and unsolicited adverse events will be recorded.
Up to 6 months
Severity of adverse events
Time Frame: Up to 6 months
The severity will be graded according to the definitions and values stated in CTCAE V04 v4.
Up to 6 months
Effect on Harvey Bradshaw Index (HBI)
Time Frame: Up to 6 months
The effect on Crohn's disease activity will be evaluated using the HBI.
Up to 6 months
Effect on inflammation, as indicated by C-reactive protein (CRP)
Time Frame: Up to 6 months
The changes in CRP from baseline will be evaluated.
Up to 6 months
Effect on inflammation, as indicated by fecal calprotectin
Time Frame: Up to 6 months
The changes in fecal calprotectin levels from baseline will be evaluated.
Up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect on the incidence and levels of AIEC
Time Frame: Up to 6 months
The secondary objective is to assess the effect of oral phage administration on the AIEC (CFU/g) in stools of patients receiving phages vs. patients receiving placebo.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intralytix, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
Icahn School of Medicine at Mount Sinai

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Hirten, MD, ICAHN School of Medicine at Mount Sinai
  • Principal Investigator: Reezwana Chowdhury, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ITX/EA-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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