EcoActive for Crohn's Disease

Not currently recruiting at 2 trial locations

Overseen By Kimberly Baytops, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Intralytix, Inc.

Must not be taking: Probiotics, Mesalamine, Antibiotics, others

Disqualifiers: Active Crohn's, Malignancies, Colitis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with inactive Crohn's disease, using an oral preparation of bacteriophages. The goal is to assess the treatment's safety and its effect on specific bacteria levels in stool. Participants will receive either the bacteriophage treatment or a placebo. Suitable candidates are adults with a history of Crohn's disease who currently show no active symptoms and have certain bacteria detected in their stool. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that your current Crohn's disease medications remain stable during the study. You should check Section 7 of the trial protocol for specific allowed and prohibited drugs.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bacteriophages, such as those in EcoActive, are likely safe. One study found that a specific mix of bacteriophages reduced inflammation in animals with inflammatory bowel disease (IBD), suggesting potential benefits for conditions like Crohn's disease.

Additionally, when healthy individuals took bacteriophages, they were safe and well-tolerated. These phages accumulated in the gut without causing harm. Although this research is still in its early stages, the results are promising for prospective participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Crohn's disease?

Researchers are excited about the bacteriophage preparation for Crohn's disease because it represents a novel approach compared to current treatments like immunosuppressants and biologics. Unlike these standard treatments, which often aim to suppress the immune system, bacteriophages offer a targeted mechanism by using viruses that specifically kill harmful bacteria in the gut. This precision could potentially reduce side effects and improve gut health more effectively. Additionally, the oral delivery of this treatment twice a day for just 15 days is straightforward and non-invasive, making it appealing for patients.

What evidence suggests that this bacteriophage preparation might be an effective treatment for Crohn's disease?

Research suggests that bacteriophage therapy could be a promising treatment for Crohn's disease. In this trial, participants in the experimental arm will receive a bacteriophage preparation. Studies have shown that certain combinations of bacteriophages can effectively target harmful bacteria like AIEC, often found in people with Crohn's. Some research in animals with inflammatory bowel disease (IBD) indicates that phages can help reduce symptoms and inflammation. However, other studies found no significant difference between phage-treated groups and those who did not receive the treatment in short-term trials. While potential exists, more evidence from human studies is needed to confirm its effectiveness. ^{3 5 6 7 8}

Who Is on the Research Team?

Robert Hirten, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Reezwana Chowdhury, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

CRP (C-reactive protein) within normal range at the Screening visit

My Crohn's disease is inactive and I feel well.

Fecal calprotectin level ≤ 150 µg/g at the Screening visit

Exclusion Criteria

I am not pregnant, nursing, or planning to become pregnant during the study.

I have had part of my colon removed.

Lack or expected lack of cooperation or compliance with the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 1mL of bacteriophage preparation or placebo orally twice a day for 15 days

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of Crohn's disease activity and inflammation markers

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Bacteriophage preparation
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Phage Experimental Treatment 1 Intervention

Dose is 1mL of bacteriophage preparation given orally twice a day for 15 days

Group II: Placebo Placebo Group 1 Intervention

Dose is 1mL of placebo given orally twice a day for 15 days

Who Is Running the Clinical Trial?

Intralytix, Inc.

Lead Sponsor

Trials

3

Recruited

160+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

MOUNT SINAI HOSPITAL

Collaborator

Trials

44

Recruited

17,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11109441/

Advances and optimization strategies in bacteriophage ... This review aims to provide a theoretical foundation for using bacteriophages as microbiome modulators in IBD treatment, paving the way for ...

2. hksmp.com hksmp.com/journals/md/article/view/434

Phage: Future Treatment Direction for inflammatory bowel ... Latest research reveals that special combinations of bacteriophages can effectively improve the symptoms of IBD model animals. This article ...

3. pasteur.fr pasteur.fr/en/research-journal/news/phage-therapy-effective-crohn-s-disease

Phage therapy effective in Crohn's disease Bacteriophages represent a new treatment option for targeting AIEC bacteria in Crohn's disease patients.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0092867422008509

Targeted suppression of human IBD-associated gut ... A Kp-targeting five-phage combination suppresses intestinal inflammation in IBD models. Phages consumed by healthy humans are safe and viable and accumulate in ...

5. journals.asm.org journals.asm.org/doi/10.1128/CMR.00136-21

Intestinal Bacteriophage Therapy: Looking for Optimal ... Three studies reported no difference between oral phage-treated and control groups over periods from 7 to 30 days posttreatment (44–46). The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8656360/

Roles of Gut Bacteriophages in the Pathogenesis and ... The present review highlights the roles of gut phages in IBD pathogenesis and explores the potentiality of phages as a therapeutic target for IBD treatment.

7. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1398652/full

Advances and optimization strategies in bacteriophage ... This review thoroughly explores the latest developments in IBD treatment and its inherent challenges, focusing on the interaction between the microbiota and ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03808103

NCT03808103 | Safety and Efficacy of EcoActive on ... The purpose of this study is to determine if EcoActive is safe and effective in people with Crohn's disease. EcoActive is a collection of bacteriophages.