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Clostridia, Cluster Xiva, Strain Relative Eisenbergiella Porci, Live

A new drug called VE202, containing live bacterial strains including Clostridia, Cluster XIVa, Strain Relative Eisenbergiella Porci, is being studied in clinical trials for the treatment of mild to moderate ulcerative colitis. This Phase 2 study aims to evaluate the efficacy and safety of VE202 in patients who have not previously received certain types of treatments for their condition.

Table of Contents

What is VE202?

VE202 is an innovative medication 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[1]. VE202 is currently undergoing a Phase 2 clinical trial to evaluate its effectiveness and safety for patients with this condition.

How VE202 Works

VE202 is a unique treatment that contains multiple strains of live bacteria. These bacteria belong to various groups, including:

  • Clostridia (Cluster XIVA and Cluster IV)
  • Bacilli (Cluster XVIII)
The medication is designed to restore balance to the gut microbiome, which is the community of microorganisms living in our digestive system. In people with ulcerative colitis, this balance is often disrupted[1].

Potential Benefits of VE202

While the full benefits of VE202 are still being studied, researchers hope that it will:

  1. Reduce inflammation in the colon and rectum
  2. Improve symptoms of ulcerative colitis, such as diarrhea and rectal bleeding
  3. Help heal the lining of the colon
  4. Provide a new treatment option for patients who haven’t responded well to other therapies
It’s important to note that these potential benefits are still being investigated in the ongoing clinical trial[1].

Current Clinical Trial

VE202 is currently being studied in a Phase 2 clinical trial. This trial is:

  • Randomized: Participants are randomly assigned to receive either VE202 or a placebo
  • Double-blind: Neither the participants nor the researchers know who is receiving the actual medication
  • Placebo-controlled: Some participants receive an inactive substance (placebo) to compare results
The main goals of this study are:
  1. To evaluate how well VE202 works in improving the appearance of the colon lining after 8 weeks of treatment
  2. To assess the safety of VE202
Researchers will be looking at whether VE202 can reduce the Mayo endoscopic subscore, which is a measure of how inflamed and damaged the colon lining appears during a medical examination[1].

Who Can Participate in the Trial?

The clinical trial has specific criteria for who can participate. Some key eligibility factors include:

  • Age: 18 to 75 years old
  • Diagnosis: Confirmed ulcerative colitis for at least 3 months
  • Disease activity: Mild to moderate ulcerative colitis, as determined by specific scoring systems
  • Treatment history: No previous use of certain medications like biologics or JAK inhibitors
There are also several exclusion criteria, such as having other digestive conditions or recent use of antibiotics or probiotics[1].

Safety Considerations

As with any new medication, safety is a top priority in the VE202 clinical trial. The researchers are closely monitoring for any side effects or adverse reactions. Some important safety points include:

  • The trial excludes people with certain medical conditions or those taking specific medications to minimize risks
  • Participants are carefully screened and monitored throughout the study
  • The trial is designed to evaluate both the effectiveness and safety of VE202
It’s important to remember that VE202 is still an experimental treatment, and its full safety profile is not yet known[1].

Aspect Details
Study Type Phase 2, randomized, double-blind, placebo-controlled
Condition Mild to moderate ulcerative colitis
Intervention VE202 (capsule containing live bacterial strains)
Primary Endpoints Endoscopic response rate at Day 56, safety assessments
Treatment Duration 8 weeks
Key Inclusion Criteria Adults 18-75 years, UC diagnosis for at least 3 months, specific disease activity criteria
Key Exclusion Criteria Prior biologic or JAK inhibitor treatment, recent antibiotic use, active infections

FAQ

  • What is VE202 and how does it work? VE202 is a capsule containing multiple strains of live bacteria, including Clostridia and Bacilli. It is designed to help restore balance to the gut microbiome, which may help reduce inflammation and improve symptoms in people with ulcerative colitis.
  • Who is eligible for this clinical trial? The trial is open to adults aged 18-75 with mild to moderate ulcerative colitis diagnosed at least 3 months prior. Participants must not have received certain previous treatments like biologics or JAK inhibitors, and must meet specific disease activity criteria.
  • How long does the treatment last in this study? The treatment period in this study lasts for 8 weeks, with the primary evaluation of effectiveness occurring at Day 56.
  • What are the main goals of this clinical trial? The main objectives are to evaluate the efficacy of VE202 in terms of endoscopic response after 8 weeks of treatment, and to assess the safety of VE202 throughout the study.
  • Are there any restrictions for participants during the trial? Yes, participants must avoid certain medications and treatments, including antibiotics, probiotics, and fecal microbiota transplantation (FMT) for specified periods before and during the trial. They must also follow contraception requirements if applicable.

Ongoing Clinical Trials on Clostridia, Cluster Xiva, Strain Relative Eisenbergiella Porci, Live

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

    Not recruiting

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

Glossary

  • Ulcerative Colitis: A chronic inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine (colon) and rectum.
  • Endoscopic Response: An improvement in the appearance of the colon lining as seen through an endoscope, which is a thin, flexible tube with a camera used to examine the inside of the colon.
  • Mayo Score: A scoring system used to assess the severity of ulcerative colitis, which takes into account stool frequency, rectal bleeding, endoscopic findings, and a physician's overall assessment.
  • Microbiome: The collection of all microorganisms, such as bacteria, that naturally live in and on our bodies, particularly in the gut.
  • Probiotic: Live microorganisms that, when administered in adequate amounts, confer a health benefit on the host.
  • Fecal Microbiota Transplantation (FMT): A procedure in which fecal matter from a healthy donor is transferred to a recipient to help restore a healthy balance of gut bacteria.
  • Biologic Agent: A type of medication made from living organisms or their products, used to treat various conditions including inflammatory bowel diseases.
  • Janus Kinase (JAK) Inhibitor: A class of medications that work by blocking specific enzymes involved in inflammation.
  • Colony Forming Unit (CFU): A unit used to estimate the number of viable bacteria or fungal cells in a sample.

References

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