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

NCT03808103 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: ITX/EA-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Crohn Disease

Keywords

Phage; Bacteriophage; AIEC

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events

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

  Up to 6 months

• Severity of adverse events

  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)

  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)

  The changes in CRP from baseline will be evaluated.

  Up to 6 months

• Effect on inflammation, as indicated by fecal calprotectin

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

  Up to 6 months

Secondary Outcomes (1)

• Effect on the incidence and levels of AIEC

  Up to 6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dose is 1mL of placebo given orally twice a day for 15 days

Biological: Placebo

Phage

EXPERIMENTAL

Dose is 1mL of bacteriophage preparation given orally twice a day for 15 days

Biological: Bacteriophage preparation

Interventions

Placebo BIOLOGICAL

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

Also known as: 0.9% saline

Placebo

Bacteriophage preparation BIOLOGICAL

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

Also known as: EcoActive

Phage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Intralytix, Inc.: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Johns Hopkins University: collaborator

Study Sites (2)

Johns Hopkins Green Spring Station

Lutherville, Maryland, 21093, United States

Location

Icahn School of Medicine at Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (1)

• 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.

  PMID: 33310655 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Robert Hirten, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Reezwana Chowdhury, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 17, 2019
• Study Start: May 1, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)