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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)
Must not have
Women who are pregnant or nursing, or plan to become pregnant during the study period
Colectomy or partial colectomy (less than ileo-transverse colonic anastomosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, nursing, or planning to become pregnant during the study.
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I have had part of my colon removed.
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I have a type of colitis.
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I have had or plan to have treatments to change my gut bacteria in the last year.
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I have a stoma in my colon or small bowel.
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I do not have any severe illnesses that are not under control.
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I have active sores near my anus.
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I have not taken antibiotics within the last 4 weeks and do not plan to during the study.
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My Crohn's disease is active with moderate to severe symptoms.
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I have a colorectal tumor or ongoing gastrointestinal bleeding.
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I have not had any cancer in the last 5 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

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 more
Secondary 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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Crohn's Disease include anti-inflammatory drugs (e.g., corticosteroids) that reduce inflammation in the gut, immunosuppressants (e.g., azathioprine) that decrease the immune system's activity to prevent it from attacking the gastrointestinal tract, and biologics (e.g., anti-TNF antibodies like infliximab) that target specific proteins involved in the inflammatory process. Antibiotics may also be used to treat infections or alter gut microbiota. These treatments are crucial as they help manage symptoms, induce and maintain remission, and prevent complications. The EcoActive trial focuses on altering gut microbiota to reduce levels of adherent-invasive E. coli (AIEC), which is significant because AIEC is associated with inflammation and disease activity in Crohn's Disease. By targeting gut bacteria, this approach aims to reduce inflammation and improve patient outcomes.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityOTHER
2,285 Previous Clinical Trials
14,843,035 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
871 Previous Clinical Trials
527,242 Total Patients Enrolled
Intralytix, Inc.Lead Sponsor
2 Previous Clinical Trials
132 Total Patients Enrolled

Media Library

Bacteriophage preparation (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03808103 — Phase 1 & 2
Crohn's Disease Research Study Groups: Phage, Placebo
Crohn's Disease Clinical Trial 2023: Bacteriophage preparation Highlights & Side Effects. Trial Name: NCT03808103 — Phase 1 & 2
Bacteriophage preparation (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03808103 — Phase 1 & 2
~1 spots leftby Sep 2024