What is the mechanism of action of this treatment?

The most common treatments for Ulcerative Colitis (UC) include anti-inflammatory drugs, immunosuppressants, and biologics. Anti-inflammatory drugs like 5-aminosalicylic acid (5-ASA) reduce inflammation in the colon lining. Immunosuppressants, such as azathioprine, decrease the immune system's activity to prevent it from attacking the colon. Biologics, like infliximab, target specific proteins involved in inflammation. Modulation of the gut microbiome, as studied in the CP101 trial, involves using probiotics or fecal microbiota transplantation to restore a healthy balance of gut bacteria, which can reduce inflammation and improve symptoms. This approach is significant for UC patients as it offers a potential treatment that targets the underlying microbial imbalances contributing to the disease.

What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis that modulate the gut microbiome include probiotics and fecal microbiota transplantation (FMT). Probiotics are generally safe with few side effects, but some patients may experience mild gastrointestinal symptoms such as gas and bloating. FMT has shown promise in some studies but can carry risks such as infection and adverse reactions to the transplanted material. Mesalamine, another common treatment, can cause side effects like nausea, headache, fever, rash, and in rare cases, more severe reactions such as pancreatitis and pneumonitis.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, primarily focusing on anti-inflammatory drugs, immunosuppressants, and biologics. Notably, treatments like mesalamine, corticosteroids, and biologics such as infliximab and adalimumab have been widely used. Recently, there has been growing interest in therapies that modulate the gut microbiome, similar to CP101. For instance, fecal microbiota transplantation (FMT) has been explored in clinical trials, although it is not yet FDA-approved specifically for Ulcerative Colitis. CP101 represents a novel approach in this area, aiming to restore a healthy gut microbiome through an oral microbiome therapeutic.

What other types of research exist?

Promising novel alternatives to CP101 for Ulcerative Colitis patients include: 1) GUT-108, a rationally designed bacterial consortium aimed at treating and preventing relapse in IBD by restoring intestinal homeostasis. 2) IL-10-expressing Escherichia coli Nissle 1917, which has shown potential in experimental colitis models by reducing inflammation. 3) l-Arabinose, a plant-derived monosaccharide that modulates gut microbiota and has demonstrated anti-inflammatory effects in colitis models.

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Microbiome Therapeutic

CP-101 for Ulcerative Colitis

Phase 1

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Summary

This trial tests CP101, a pill that adds good bacteria to the gut, on people with mild-to-moderate Ulcerative Colitis. The goal is to see if these good bacteria can help reduce inflammation and improve symptoms.

Who is the study for?

Adults over 18 with mild-to-moderate Ulcerative Colitis extending at least 15 cm from the anal verge can join. They must have stable medication use and a recent colonoscopy confirming their condition. Excluded are those with severe UC, recent antibiotic or investigational drug use, certain infections, prior FMT treatment, significant medical conditions that could affect results, or inability to ingest capsules.

What is being tested?

The trial is testing CP101, an oral microbiome therapeutic for Ulcerative Colitis. Participants will be randomly assigned to receive either a short or extended induction dosing of CP101. The study will monitor changes in the microbiome over several weeks up to Week 24.

What are the potential side effects?

As this is an exploratory Phase 1 trial primarily focused on safety and efficacy, specific side effects of CP101 are not detailed but may include typical drug-related gastrointestinal symptoms and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate engraftment of CP101-associated microbes after extended induction compared to the short induction arm

To evaluate the safety and tolerability of CP101

Secondary study objectives

To evaluate the effect of CP101 on induction of clinical remission

To evaluate the effect of CP101 on induction of clinical response

To evaluate the effect of CP101 on induction of endoscopic remission

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CP101Experimental Treatment1 Intervention

Extended Induction: Participants will receive the short induction dose of CP101 comprising 10 capsules daily for 5 days. Participants in this arm will then receive an extended induction daily dose of five CP101 capsules through Week 8.

Group II: CP101 + PlaceboPlacebo Group1 Intervention

Short Induction: Participants will receive the short induction dose of CP101 comprising 10 capsules daily for 5 days. Participants in this arm will then receive 5 capsules of placebo through Week 8.

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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

The most common treatments for Ulcerative Colitis (UC) include anti-inflammatory drugs, immunosuppressants, and biologics. Anti-inflammatory drugs like 5-aminosalicylic acid (5-ASA) reduce inflammation in the colon lining. Immunosuppressants, such as azathioprine, decrease the immune system's activity to prevent it from attacking the colon. Biologics, like infliximab, target specific proteins involved in inflammation. Modulation of the gut microbiome, as studied in the CP101 trial, involves using probiotics or fecal microbiota transplantation to restore a healthy balance of gut bacteria, which can reduce inflammation and improve symptoms. This approach is significant for UC patients as it offers a potential treatment that targets the underlying microbial imbalances contributing to the disease.

Probiotics in the Treatment of Inflammatory Bowel Disease in Adulthood: A Systematic Review.