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Bacilli, Cluster Xvii, Strain Relative Clostridium_Aq Innocuum, Live

This article discusses the clinical trials of VE303, a novel drug containing live bacterial strains, including Bacilli, Cluster XVII, Strain Relative Clostridium_Aq Innocuum. The trials aim to evaluate VE303’s effectiveness in preventing recurrent Clostridioides difficile infection (CDI), a serious bacterial infection affecting the digestive system. The study focuses on assessing the drug’s safety, efficacy, and impact on patients’ quality of life compared to a placebo.

Table of Contents

What is VE303?

VE303 is an investigational medicine being developed to prevent the recurrence of Clostridioides difficile infection (CDI). It is a capsule that contains live bacteria, specifically designed to restore the balance of good bacteria in your gut[1]. VE303 is made up of eight different types of beneficial bacteria, including one called Bacilli, Cluster XVII, strain relative Clostridium_AQ innocuum.

How does VE303 work?

VE303 works by introducing helpful bacteria into your digestive system. These bacteria are thought to help fight off the harmful C. difficile bacteria that cause infection. By restoring a healthy balance of bacteria in your gut, VE303 aims to prevent C. difficile from coming back after you’ve been treated with antibiotics[1].

What condition does VE303 treat?

VE303 is being studied for the prevention of recurrent Clostridioides difficile infection (CDI)[1]. CDI is a serious intestinal infection that can cause severe diarrhea, abdominal pain, and in some cases, life-threatening complications. It often occurs after a person has taken antibiotics, which can disrupt the normal balance of bacteria in the gut. Some people experience repeated episodes of CDI, which is called recurrent CDI.

Clinical Trial Details

A clinical trial called the RestoratiVE303 Study is currently underway to test how well VE303 works compared to a placebo (a capsule with no active ingredients)[1]. This is a Phase 3 study, which means it’s in an advanced stage of testing. The main goal of the study is to see if VE303 can reduce the number of people who experience a recurrence of CDI within 8 weeks of treatment.

Who can participate in the VE303 trial?

The trial is looking for participants who meet certain criteria, including[1]:

  • People aged 12 years or older (18 years or older in some countries)
  • Those who have had at least one previous episode of CDI in the last 6 months
  • Individuals who have recently completed a course of antibiotics for CDI

There are also specific criteria for older adults (75 years or older) or those with certain risk factors. Your doctor can help determine if you’re eligible for the study.

What to expect during the trial

If you participate in the trial, here’s what you can expect[1]:

  1. You’ll be randomly assigned to receive either VE303 or a placebo.
  2. You’ll take the assigned treatment (VE303 or placebo) orally for 14 days.
  3. You’ll be followed up for 24 weeks to see if you experience any recurrence of CDI.
  4. Throughout the study, you’ll have various tests and assessments to monitor your health and the effectiveness of the treatment.

Potential Benefits and Risks

While VE303 shows promise in preventing recurrent CDI, it’s important to remember that it’s still being studied. Potential benefits may include a reduced risk of CDI recurrence, but as with any medical treatment, there may also be risks or side effects[1]. The study team will monitor participants closely for any adverse effects.

If you’re interested in learning more about VE303 or the RestoratiVE303 Study, talk to your healthcare provider. They can provide more information and help determine if participating in the trial might be right for you.

Aspect Details
Study Drug VE303 (containing multiple live bacterial strains, including Bacilli, Cluster XVII, Strain Relative Clostridium_Aq Innocuum)
Target Condition Prevention of recurrent Clostridioides difficile infection (CDI)
Study Design Randomized, double-blind, placebo-controlled Phase 3 study
Primary Objective Compare CDI recurrence rate at Week 8 between VE303 and placebo groups
Key Secondary Objectives Assess safety, evaluate CDI recurrence rates at Weeks 12 and 24, measure VE303 bacterial strain detection and abundance, assess quality of life and CDI symptoms
Participant Groups Recurrent CDI (rCDI) and high-risk primary CDI (pCDI-hr) populations
Treatment Duration 14 days of oral VE303 or placebo administration
Follow-up Period 24 weeks
Key Inclusion Criteria Age ≥12 years (or ≥18 in some countries), laboratory-confirmed CDI episode, completion of standard antibiotic therapy
Key Exclusion Criteria Chronic diarrhea, pregnancy, certain medical conditions (e.g., celiac disease, inflammatory bowel disease), recent use of probiotics or other CDI treatments

FAQ

  • What is VE303 and what is it being tested for? VE303 is a drug containing multiple live bacterial strains, including Bacilli, Cluster XVII, Strain Relative Clostridium_Aq Innocuum. It is being tested for the prevention of recurrent Clostridioides difficile infection (CDI), a serious bacterial infection that affects the digestive system.
  • Who can participate in the VE303 clinical trial? The trial includes two groups: those with recurrent CDI (rCDI) aged 12 years and older, and those at high risk for primary CDI (pCDI-hr) who are either 75 years and older or have specific risk factors. Participants must have a laboratory-confirmed CDI episode and meet other eligibility criteria.
  • How is the VE303 clinical trial conducted? The trial is randomized, double-blind, and placebo-controlled. Participants receive either VE303 or a placebo orally for 14 consecutive days after completing standard antibiotic treatment for CDI. They are then followed up for 24 weeks to assess the drug's effectiveness and safety.
  • What are the main objectives of the VE303 clinical trial? The primary objective is to compare the CDI recurrence rate at Week 8 between VE303 and placebo groups. Secondary objectives include assessing safety, evaluating CDI recurrence rates at Weeks 12 and 24, measuring VE303 bacterial strain detection and abundance, and assessing health-related quality of life and CDI symptoms.
  • Are there any special considerations for participating in the VE303 trial? Yes, participants must not have certain medical conditions like chronic diarrhea, celiac disease, or inflammatory bowel disease. They should not have used probiotics within 2 weeks before the trial or received certain other treatments for CDI. Pregnant or breastfeeding individuals are also excluded from the trial.

Ongoing Clinical Trials on Bacilli, Cluster Xvii, Strain Relative Clostridium_Aq Innocuum, Live

  • Study on VE303 for Preventing Recurrent C. difficile Infection in Patients

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Czechia Denmark France Germany +8

Glossary

  • Clostridioides difficile infection (CDI): A bacterial infection that affects the digestive system, causing diarrhea and other gastrointestinal symptoms. It often occurs after antibiotic use and can be recurrent or difficult to treat.
  • VE303: An investigational drug containing multiple live bacterial strains, including Bacilli, Cluster XVII, Strain Relative Clostridium_Aq Innocuum, designed to prevent recurrent Clostridioides difficile infection.
  • Randomized, double-blind, placebo-controlled study: A type of clinical trial where participants are randomly assigned to receive either the study drug or a placebo. Neither the participants nor the researchers know who receives which treatment until the study is completed.
  • Standard of Care (SoC) antibiotic therapy: The currently accepted treatment method for a particular condition. In this study, it refers to the antibiotics used to treat the initial CDI episode before administering VE303 or placebo.
  • Recurrent CDI: The reoccurrence of Clostridioides difficile infection after an initial episode has been successfully treated.
  • Bristol stool scale: A medical aid used to classify the form of human feces into seven categories. In this study, it's used to assess the consistency of bowel movements.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure.
  • Colonization: The presence and growth of microorganisms in or on a host without causing infection or disease. In this study, it refers to the establishment of VE303 bacterial strains in the gut.
  • Quality of life: A measure of an individual's overall well-being and ability to function in daily life, often used in clinical trials to assess the impact of a treatment on patients' lives.
  • Microbiota: The community of microorganisms, including bacteria, viruses, and fungi, that live in or on the human body, particularly in the gut.

References

  1. http://clinicaltrials.eu/trial/study-on-ve303-for-preventing-recurrent-c-difficile-infection-in-patients/