ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2019-05-01

Study Completion:2026-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03808103

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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

Principal Investigator

Robert Hirten, MD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Reezwana Chowdhury, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Green Spring Station

Lutherville, Maryland, 21093

United States

Icahn School of Medicine at Mount Sinai Hospital

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Intralytix, Inc.

Robert Hirten, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
Reezwana Chowdhury, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

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 Registration Dates

Study Start Date2019-05-01

Study Completion Date2026-06-01

Study Record Updates

Study Start Date2019-05-01

Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

Phage
Bacteriophage
AIEC

Additional Relevant MeSH Terms

Crohn Disease