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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03808103
Recruitment Status : Recruiting
First Posted : January 17, 2019
Last Update Posted : January 9, 2023
Sponsor:
Collaborator:
MOUNT SINAI HOSPITAL
Information provided by (Responsible Party):
Intralytix, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Biological: Placebo Biological: Bacteriophage preparation Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arms and Interventions
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Arm Intervention/treatment
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 Name: 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 Name: EcoActive


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 6 months ]
    The number of solicited and unsolicited adverse events will be recorded.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03808103


Contacts
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Contact: Alexander Sulakvelidze, PhD 410-625-2533 asulakvelidze@intralytix.com
Contact: Jennifer Schwartz, PhD 667-215-2597 jschwartz@intralytix.com

Locations
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United States, New York
The Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Amy Nolan    212-824-7699      
Sub-Investigator: Robert Hirten, MD         
Sponsors and Collaborators
Intralytix, Inc.
MOUNT SINAI HOSPITAL
Investigators
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Principal Investigator: Jean-Frederic Colombel, MD MOUNT SINAI HOSPITAL
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Intralytix, Inc.
ClinicalTrials.gov Identifier: NCT03808103    
Other Study ID Numbers: ITX/EA-002
First Posted: January 17, 2019    Key Record Dates
Last Update Posted: January 9, 2023
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Intralytix, Inc.:
Phage
Bacteriophage
AIEC
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases