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)

Trial Information
Who is this study for? Adult patients with Inactive Crohn's Disease
What treatments are being studied? EcoActive Bacteriophage
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Minimum Age:
18
Healthy Volunteers:
Accepts Healthy Volunteers

• 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.

Where is this trial taking place?
United States
New York
The Mount Sinai Hospital
Recruiting
New York
Who do I contact about this trial?
Primary
Alexander Sulakvelidze, PhD
asulakvelidze@intralytix.com
410-625-2533
Backup
Jennifer Schwartz, PhD
jschwartz@intralytix.com
667-215-2597
When is this trial taking place?
Start Date: May 1, 2019
Estimated Completion Date: June 2023
How many participants will be in this trial?
Target number of participants: 30
What treatment is being studied in this trial?
Placebo Comparator: Placebo
Dose is 1mL of placebo given orally twice a day for 15 days
Experimental: Phage
Dose is 1mL of bacteriophage preparation given orally twice a day for 15 days
Who are the authors of this trial?
Robert Hirten, Jean-Frederic Colombel

This content was sourced from clinicaltrials.gov