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Clostridia, Cluster Xiva, Strain Relative Eisenbergiella Tayi, Live

A phase 2 clinical trial is underway to evaluate the efficacy and safety of VE202, a new drug containing live bacterial strains, for the treatment of mild-to-moderate ulcerative colitis. This randomized, double-blind, placebo-controlled study aims to assess the drug’s potential in improving endoscopic response and overall patient outcomes.

Table of Contents

What is VE202?

VE202 is an experimental drug being studied as a potential treatment for 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 a capsule containing live bacteria, also known as a live biotherapeutic product.

How VE202 Works

VE202 contains multiple strains of live bacteria, including various types of Clostridia and Bacilli[1]. These bacteria are thought to help 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. By introducing beneficial bacteria, VE202 may help reduce inflammation and improve symptoms of ulcerative colitis.

Current Research on VE202

VE202 is currently being studied in a Phase 2 clinical trial. This is a randomized, double-blind, placebo-controlled study, which means that participants are randomly assigned to receive either VE202 or a placebo, and neither the participants nor the researchers know who is receiving which treatment[1].

The main objectives of this study are:

  • To evaluate how effective VE202 is in improving the appearance of the colon lining (endoscopic response) after 8 weeks of treatment
  • To assess the safety of VE202

Potential Benefits of VE202

If successful, VE202 could offer several potential benefits for patients with mild to moderate ulcerative colitis:

  • It may provide a new treatment option for patients who have not yet tried biologic agents or other advanced therapies
  • As a capsule taken by mouth, it could be more convenient than some other treatments
  • By targeting the gut microbiome, it may offer a different approach to managing ulcerative colitis compared to existing treatments

Eligibility Criteria for VE202 Clinical Trial

To participate in the VE202 clinical trial, patients must meet certain criteria[1]. Some key eligibility requirements include:

  • Age 18 to 75 years
  • Diagnosed with ulcerative colitis at least 3 months before the study
  • Have active mild to moderate ulcerative colitis, as determined by specific scoring systems
  • Have not previously received certain types of treatments for ulcerative colitis, such as biologic agents
  • If taking other medications for ulcerative colitis, the doses must have been stable for a certain period

There are also several factors that would exclude a person from participating in the trial, such as having Crohn’s disease, active infections, or certain other medical conditions.

Safety Considerations

As with any experimental treatment, there are potential risks and safety considerations to be aware of[1]:

  • The study is closely monitoring for any side effects or adverse events related to VE202
  • Participants are not allowed to use certain other treatments during the study, such as probiotics or antibiotics, which could interfere with VE202
  • Pregnant or breastfeeding women are not eligible to participate in the study
  • Participants must agree to use effective birth control methods during the study and for a period afterward

It’s important to note that as a Phase 2 clinical trial, the full safety profile and effectiveness of VE202 are still being evaluated. Patients interested in this treatment should discuss it with their healthcare provider and consider all available options for managing their ulcerative colitis.

Aspect Details
Study Drug VE202 (capsule containing live bacterial strains)
Condition Mild-to-moderate ulcerative colitis
Study Type Phase 2, randomized, double-blind, placebo-controlled
Primary Objective Evaluate efficacy in terms of endoscopic response at Day 56
Treatment Duration 8 weeks
Key Inclusion Criteria Adults 18-75 years, UC diagnosis for at least 3 months, active mild to moderate disease
Key Exclusion Criteria History of Crohn’s disease, recent antibiotic use, active infections
Primary Endpoints Endoscopic response rate, safety (Grade ≥3 TEAEs and SAEs related to study drug)

FAQ

  • What is VE202 and how does it work? VE202 is a capsule containing multiple strains of live bacteria, primarily from the Clostridia and Bacilli clusters. It is designed to help restore balance to the gut microbiome, which may help reduce inflammation and improve symptoms in patients with ulcerative colitis.
  • Who is eligible to participate in this clinical trial? The trial is open to adults aged 18-75 with a documented diagnosis of mild-to-moderate ulcerative colitis for at least 3 months. Participants must have active disease and meet specific criteria regarding disease severity and previous treatments.
  • What is the main goal of this clinical trial? The primary objective is to evaluate the efficacy of VE202 in terms of endoscopic response after 8 weeks of treatment. This means assessing whether there is a reduction in the visible signs of inflammation in the colon as observed during a flexible sigmoidoscopy.
  • How long does the treatment last in this trial? The treatment period in this trial lasts for 8 weeks. During this time, participants will receive either VE202 or a placebo, and their response to the treatment will be monitored.
  • What are the potential benefits and risks of participating in this trial? Potential benefits include improvement in ulcerative colitis symptoms and contributing to the development of new treatments. Risks may include side effects from the study drug, which are being closely monitored. The trial is designed to assess both the efficacy and safety of VE202, including any treatment-related adverse events.

Ongoing Clinical Trials on Clostridia, Cluster Xiva, Strain Relative Eisenbergiella Tayi, 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 (UC): 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 viewed through an endoscope, typically indicating a reduction in inflammation and ulceration.
  • Flexible Sigmoidoscopy: A medical procedure that allows doctors to view the lower part of the colon using a flexible tube with a camera on the end.
  • Placebo: An inactive substance that looks like the drug being tested but contains no active ingredients. It's used to compare the effects of the real drug.
  • Randomized, Double-Blind Study: A type of clinical trial where participants are randomly assigned to receive either the study drug or a placebo, and neither the participants nor the researchers know who is receiving which treatment.
  • Microbiome: The collection of all microorganisms, such as bacteria, that naturally live in and on our bodies, particularly in the gut.
  • Colony Forming Unit (CFU): A unit used to estimate the number of viable bacteria or fungal cells in a sample.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

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