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Inactive Crohn's Disease - Healing Genes
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Inactive Crohn’s Disease

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

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)


Phase 1 / 2

DESCRIPTION:

Researchers at Mount Sinai Hospital in NY are recruiting patients with inactive Crohn’s Disease to trial a new treatment for Adherent Invasive Escherichia coli (AIEC). The new treatment, called EcoActive, is a collection of bacteriophages (or phages) which are viruses that infect only bacteria. The phages are genetically screened for their preference to attack only AIEC, which is associated with worse inflammation in Crohn’s. 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.

Participants would receive a dose of drug (or placebo, you will not know which), by mouth twice a day for 15 days.


PATIENT MUST:

  • Be 18 years of age or older
  • Have inactive Crohn’s disease in clinical and objective remission with a Harvey-Bradshaw Index (HBI) < 4
  • Have AIEC detected in the stool
  • Not be pregnant, and be willing to utilize contraception for the duration of the study

THE STUDY INVOLVES:

  1. Screening to confirm acceptance to the study.
  2. EcoActive (or placebo) is given orally twice a day for 15 days.
  3. Follow up, including lab and fecal assessments, may continue for up to 6 months

LOCATIONS & CONTACTS:
Trials will take place at The Mount Sinai Hospital in New York, NY. Map.

Contact:
Alexander Sulakvelidze, PhD  |  410-625-2533  |  [email protected]
Contact: Joelle Woolston, MS  |  443-275-9709  |  [email protected]
 
SPONSORS
Intralytix, Inc.
MOUNT SINAI HOSPITAL
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT03808103

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