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Crohn DiseasePhase 1/2NCT03808103

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

A Phase 1/2 study testing Bacteriophage preparation in people with Crohn Disease, run by Intralytix, Inc. at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Crohn Disease
What is being tested?
Bacteriophage preparation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesUnited States
Study dates
1 May 2019to 1 Jun 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female ≥ 18 years of age
  • Inactive Crohn's disease in clinical and objective remission with a Harvey-Bradshaw Index (HBI) < 4
  • 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).
  • Crohn's disease history ≥ 6-month duration
  • CRP (C-reactive protein) within normal range at the Screening visit (based on normal range of the local laboratory)
  • Fecal calprotectin level ≤ 150 µg/g at the Screening visit
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  • AIEC detected in the stool
  • 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).
  • Negative pregnancy test for women of childbearing age (menarche to menopause)
  • Patient understands the study procedures, and can sign the informed consent, and the authorization to release relevant protected health information to the Study Investigator.

Who cannot join

  • 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
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  • 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.
  • Topical gastrointestinal treatment (e.g., enemas) in the 2 weeks prior to the Screening visit or planned during the study period
  • 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.
  • Receipt of antibiotics 4 weeks before the Screening visit or planned during the study period.
  • Known allergy or hypersensitivity to an excipient in the study drug or placebo
  • Psychological or linguistic incapability to sign the informed consent.
  • Lack or expected lack of cooperation or compliance with the study.
  • Receipt of mesalamine based therapies within 4 weeks of the screening visit.
  • Severe psychiatric, psychological, or neurological disorders.
  • Alcohol, drug or medication abuse within the past year.
  • Subject who cannot be contacted in case of emergency.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Johns Hopkins Green Spring Station

    Lutherville, Maryland, 21093

  • Icahn School of Medicine at Mount Sinai Hospital

    New York, New York, 10029

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Crohn Disease
Being tested
Placebo, Bacteriophage preparation
Keywords
Phage, Bacteriophage, AIEC
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboBiological

    Also called 0.9% saline

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

  • Bacteriophage preparationBiological

    Also called EcoActive

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

Study groups in NCT03808103
Study groupRoleWhat they receive
PlaceboPlacebo comparatorDose is 1mL of placebo given orally twice a day for 15 days
Receives: Biological: Placebo
PhageExperimentalDose is 1mL of bacteriophage preparation given orally twice a day for 15 days
Receives: Biological: Bacteriophage preparation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    The number of solicited and unsolicited adverse events will be recorded.

    Measured: Up to 6 months

  2. Severity of adverse events

    The severity will be graded according to the definitions and values stated in CTCAE V04 v4.

    Measured: Up to 6 months

  3. Effect on Harvey Bradshaw Index (HBI)

    The effect on Crohn's disease activity will be evaluated using the HBI.

    Measured: Up to 6 months

  4. Effect on inflammation, as indicated by C-reactive protein (CRP)

    The changes in CRP from baseline will be evaluated.

    Measured: Up to 6 months

  5. Effect on inflammation, as indicated by fecal calprotectin

    The changes in fecal calprotectin levels from baseline will be evaluated.

    Measured: Up to 6 months

Secondary outcomes (1)

  1. Effect on the incidence and levels of AIEC

    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.

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2019
  2. Study start1 May 2019
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03808103
Sponsor's protocol ID
ITX/EA-002
Status last verified
Jun 2025
First submitted
4 Jan 2019
Last updated
15 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lenneman BR, Fernbach J, Loessner MJ, Lu TK, Kilcher S. Enhancing phage therapy through synthetic biology and genome engineering. Curr Opin Biotechnol. 2021 Apr;68:151-159. doi: 10.1016/j.copbio.2020.11.003. Epub 2020 Dec 10.

    PubMed 33310655

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Bacteriophage preparation in people with Crohn Disease, run by Intralytix, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03808103, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.

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