#1 Clinical Trials Search in Europe

Bacilli, Cluster Xviii, Strain Relative Thomasclavelia Ramosum, Live

This article explores the ongoing clinical trials of VE202, a novel drug containing live bacterial strains, including Bacilli, Cluster XVIII, Strain Relative Thomasclavelia Ramosum. The study focuses on evaluating the efficacy and safety of VE202 in treating patients with mild to moderate ulcerative colitis, a chronic inflammatory bowel disease. The trials aim to assess the drug’s potential in improving endoscopic response and overall patient outcomes.

Table of Contents

What is VE202?

VE202 is an experimental medication being developed to treat mild-to-moderate ulcerative colitis. It is also known by the alternative name JNJ-72537634[1]. VE202 is a capsule that contains live bacteria, which are believed to help improve the health of the gut[1].

How Does VE202 Work?

VE202 is a type of treatment called a live biotherapeutic product. It contains various strains of live bacteria that are thought to be beneficial for gut health. These bacteria include different types from groups called Bacilli and Clostridia[1]. The idea behind this treatment is that these good bacteria may help restore balance to the gut microbiome (the community of microorganisms living in our intestines), which is often disrupted in people with ulcerative colitis.

What Condition Does VE202 Treat?

VE202 is being developed to treat mild-to-moderate ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine (colon) and rectum. Symptoms can include diarrhea, abdominal pain, and rectal bleeding[1].

Clinical Trial Details

VE202 is currently being studied in a Phase 2 clinical trial. This means that while it has shown promise in earlier studies, it is still being tested to determine how well it works and if it’s safe for patients with ulcerative colitis. Here are some key details about the trial:

  • It’s a randomized, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either VE202 or a placebo (a pill with no active ingredient), and neither the participants nor the researchers know who is receiving which treatment[1].
  • The treatment lasts for 8 weeks[1].
  • The main goal is to see if VE202 can improve the appearance of the colon lining when examined with a flexible sigmoidoscopy (a procedure that allows doctors to look inside the lower part of the colon)[1].
  • The study will also closely monitor the safety of VE202[1].

Who Can Participate in the Trial?

The trial has specific criteria for who can participate. Some key points include:

  • Participants must be between 18 and 75 years old[1].
  • They must have been diagnosed with ulcerative colitis at least 3 months before the study[1].
  • Their ulcerative colitis must be active but mild to moderate in severity[1].
  • Participants must not have taken certain other medications for ulcerative colitis, such as biologic agents or JAK inhibitors[1].

Potential Benefits and Risks

As with any experimental treatment, there are potential benefits and risks to consider:

Potential Benefits:

  • VE202 may help improve the symptoms of ulcerative colitis and the appearance of the colon lining[1].
  • It may offer a new treatment option for people who haven’t responded well to other treatments.

Potential Risks:

  • As this is an experimental treatment, there may be unknown side effects[1].
  • The treatment may not work for everyone.
  • There’s a chance of receiving a placebo instead of the active treatment in the clinical trial.

It’s important to note that more research is needed to fully understand the effectiveness and safety of VE202. If you’re interested in this treatment or clinical trial, it’s crucial to discuss it with your healthcare provider to determine if it might be appropriate for you.

Aspect Details
Study Type Randomized, Double-Blind, Placebo-Controlled, Phase 2
Condition Mild to Moderate Ulcerative Colitis
Intervention VE202 (capsule containing live bacterial strains)
Primary Outcome Endoscopic response rate at Day 56
Treatment Duration 8 weeks
Key Inclusion Criteria Age 18-75, UC diagnosis for ≥3 months, active mild to moderate UC
Key Exclusion Criteria Prior biologic treatment, recent antibiotics or probiotics use, active infections
Safety Monitoring Grade ≥3 Treatment-emergent adverse events, Serious adverse events

FAQ

  • What is VE202 and how is it being studied? VE202 is a capsule containing multiple live bacterial strains, including Bacilli, Cluster XVIII, Strain Relative Thomasclavelia Ramosum. It is being studied in a randomized, double-blind, placebo-controlled Phase 2 clinical trial for patients with mild to moderate ulcerative colitis.
  • Who is eligible to participate in the VE202 clinical trial? Eligible participants are adults aged 18 to 75 with a documented diagnosis of mild to moderate ulcerative colitis for at least 3 months. They must have active disease as defined by specific criteria and must not have received certain previous treatments like biologics or JAK inhibitors.
  • What is the main goal of the VE202 clinical trial? The main goal is to evaluate the efficacy of 8 weeks of VE202 treatment in terms of endoscopic response at Day 56, as well as to assess the safety of VE202 throughout the study.
  • How is the effectiveness of VE202 measured in the trial? The primary measure of effectiveness is the endoscopic response rate, defined as a reduction of 1 point or more in the Mayo endoscopic subscore on flexible sigmoidoscopy from baseline to Day 56.
  • What are the safety considerations in the VE202 trial? The trial closely monitors for any treatment-related adverse events, particularly those of Grade 3 or higher, and any serious adverse events related to VE202 or its placebo. Participants are also screened for allergies to VE202 components and recent infections.

Ongoing Clinical Trials on Bacilli, Cluster Xviii, Strain Relative Thomasclavelia Ramosum, Live

  • Study on VE202 for Patients with Mild-to-Moderate Ulcerative Colitis

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Hungary Lithuania The Netherlands Poland

Glossary

  • Ulcerative Colitis (UC): A chronic inflammatory bowel disease that causes inflammation and ulcers in the digestive tract, primarily affecting the large intestine (colon) and rectum.
  • Endoscopic Response: An improvement in the appearance of the colon as viewed through an endoscope, typically measured by a reduction in inflammation and ulceration.
  • Mayo Endoscopic Subscore: A part of the Mayo Score used to assess the severity of ulcerative colitis, specifically focusing on the appearance of the colon during endoscopy.
  • Flexible Sigmoidoscopy: A medical procedure that allows doctors to view the lower part of the colon (sigmoid) and rectum using a flexible, lighted tube.
  • Placebo-Controlled: A study design where some participants receive an inactive substance (placebo) instead of the actual drug, allowing researchers to compare the true effects of the treatment.
  • Double-Blind: A study design where neither the participants nor the researchers know who is receiving the actual treatment and who is receiving the placebo.
  • Phase 2 Clinical Trial: A stage of drug testing that focuses on evaluating the effectiveness and side effects of a treatment in a larger group of patients with the target condition.
  • Biologic Agent: A type of medication derived from living organisms, often used in treating inflammatory conditions like ulcerative colitis.
  • Janus Kinase (JAK) Inhibitor: A class of medication that works by blocking specific enzymes involved in the inflammatory process.
  • Colony Forming Unit (CFU): A measure used to estimate the number of viable bacteria or fungal cells in a sample, often used to quantify probiotic or live bacterial treatments.

References

  1. http://clinicaltrials.eu/trial/study-on-ve202-for-patients-with-mild-to-moderate-ulcerative-colitis/