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Virus Therapy
EcoActive for Crohn's Disease
Phase 1 & 2
Recruiting
Led By Reezwana Chowdhury, MD
Research Sponsored by Intralytix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Inactive Crohn's disease in clinical and objective remission with a Harvey-Bradshaw Index (HBI) < 4
Negative pregnancy test for women of childbearing age (menarche to menopause)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial will test whether a new drug is safe for patients with Crohn's disease and if it can lower levels of a harmful bacteria in the intestine.
Who is the study for?
Adults over 18 with a history of Crohn's disease for at least 6 months, currently in remission as shown by low levels of inflammation markers and no active symptoms. They must not have had any major gut surgery or be taking certain medications that could affect the study results. Women who can become pregnant must use effective birth control during the trial.Check my eligibility
What is being tested?
The trial is testing EcoActive, a bacteriophage preparation taken orally, against a placebo to see if it's safe and how it affects E. coli levels in stool samples from patients with inactive Crohn's disease.See study design
What are the potential side effects?
Specific side effects are not listed but generally may include reactions to ingredients in EcoActive or the placebo. Participants will be monitored for any adverse effects related to the treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My Crohn's disease is inactive and I feel well.
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I am not pregnant.
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I have had Crohn's disease for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effect on Harvey Bradshaw Index (HBI)
Effect on inflammation, as indicated by C-reactive protein (CRP)
Effect on inflammation, as indicated by fecal calprotectin
+2 moreSecondary outcome measures
Effect on the incidence and levels of AIEC
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PhageExperimental Treatment1 Intervention
Dose is 1mL of bacteriophage preparation given orally twice a day for 15 days
Group II: PlaceboPlacebo Group1 Intervention
Dose is 1mL of placebo given orally twice a day for 15 days
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Johns Hopkins UniversityOTHER
2,260 Previous Clinical Trials
14,820,750 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
860 Previous Clinical Trials
524,446 Total Patients Enrolled
Intralytix, Inc.Lead Sponsor
2 Previous Clinical Trials
132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, nursing, or planning to become pregnant during the study.I have had part of my colon removed.My Crohn's disease is inactive and I feel well.I have a type of colitis.I have had or plan to have treatments to change my gut bacteria in the last year.I have a stoma in my colon or small bowel.I am 18 years old or older.My Crohn's disease medication will not change during the study.I am taking probiotic supplements in pill or tablet form.I do not have any severe illnesses that are not under control.I am using, and will continue to use, effective birth control during the study.I am not pregnant.I haven't used any bowel cleansing methods for tests in the last 4 weeks and don't plan to during the study.I have active sores near my anus.I have not taken antibiotics within the last 4 weeks and do not plan to during the study.My Crohn's disease is active with moderate to severe symptoms.I have a colorectal tumor or ongoing gastrointestinal bleeding.I have taken mesalamine-based treatments within the last 4 weeks.I have had Crohn's disease for at least 6 months.I have not had any cancer in the last 5 years.I haven't used any topical treatments for my gut in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Phage
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any patients who can still join this clinical trial?
"That is correct. The clinical trial, which was posted on May 1st 2019 and updated on August 22nd 2022, is still recruiting patients. So far, 30 individuals have been enrolled at the 1 site."
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