What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Crohn's Disease that alter gut microbiota, such as probiotics and prebiotics, are generally well-tolerated but can cause mild gastrointestinal symptoms like gas and bloating. Probiotics may pose a risk of systemic infections in immunocompromised patients. Dietary interventions, like the Mediterranean diet, are safe but may be challenging to maintain. Immunomodulators (e.g., azathioprine, methotrexate) can cause bone marrow suppression, liver toxicity, and increased infection risk. Corticosteroids are effective for short-term use but have significant side effects, including weight gain, osteoporosis, and adrenal suppression.

What prior FDA approvals exist?

The FDA has approved several treatments for Crohn's Disease, primarily focusing on reducing inflammation and modulating the immune response. Notable drugs include anti-TNF agents like infliximab and adalimumab, which target tumor necrosis factor to reduce inflammation. Vedolizumab, an integrin receptor antagonist, is another approved treatment that works by preventing inflammatory cells from entering the gut. While specific FDA-approved treatments targeting gut microbiota like EcoActive are not mentioned, the use of probiotics and dietary modifications are being explored in clinical settings to manage Crohn's Disease by altering gut microbiota.

What other types of research exist?

Promising alternatives to EcoActive for Crohn's Disease patients include: 1) Polyphenol-enriched diets, which have been shown to support IBD remission by affecting intestinal dysbiosis. 2) Low-FODMAP diets, which can improve abdominal symptoms in IBD patients. 3) Specific Carbohydrate Diet (SCD) and Mediterranean Diet, both of which have shown comparable remission rates in studies. 4) Probiotics, such as Lactobacillus plantarum and Bifidobacterium breve, which may help in reducing symptoms and altering gut microbiota. 5) Synbiotics, a combination of prebiotics and probiotics, which have shown benefits in other gastrointestinal conditions and may be beneficial for Crohn's Disease.

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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

Summary

This trial will test if EcoActive, a treatment made of special viruses, is safe and effective for people with inactive Crohn's disease. EcoActive targets and kills harmful bacteria in the gut, which can worsen inflammation, without affecting good bacteria. This may reduce the need for antibiotics and their associated risks.

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.

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.

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.

Select...

My Crohn's disease is active with moderate to severe symptoms.

Select...

I have a colorectal tumor or ongoing gastrointestinal bleeding.

Select...

I have not had any cancer in the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

0 / 14Eligibility criteria met

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.