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Streptococcus Agalactiae

This article discusses a clinical trial investigating the use of Buccalin® tablets, which contain bacterial lysates including Streptococcus agalactiae, for preventing recurrent lower respiratory tract infections (RLRTIs) in adults. The study aims to confirm and gather more clinical data on the effectiveness and safety of this treatment approach.

Table of Contents

What is Buccalin?

Buccalin is a medication classified as a bacterial vaccine[1]. It comes in the form of gastro-resistant tablets, which means the tablets are designed to pass through the stomach and dissolve in the intestines[1]. Buccalin is primarily used to prevent recurrent lower respiratory tract infections (RLRTIs) in adults[1].

Medical Conditions Treated

Buccalin is specifically designed to prevent recurrent lower respiratory tract infections (RLRTIs)[1]. These infections include:

  • Acute bronchitis: An inflammation of the bronchial tubes, usually caused by viruses or bacteria
  • Exacerbations of chronic lung diseases, such as:
    • Asthma: A condition causing airways to narrow and swell, producing extra mucus
    • COPD (Chronic Obstructive Pulmonary Disease): A group of lung diseases that block airflow and make breathing difficult
    • Bronchiectasis: A condition where the bronchial tubes of the lungs are permanently damaged and widened
RLRTIs are defined as two or more episodes of respiratory tract infections within 12 months[1].

Active Ingredients

Buccalin contains four bacterial components[1]:

  1. Streptococcus agalactiae: A type of bacteria that can cause pneumonia and other respiratory infections
  2. Haemophilus influenzae: A bacterium that can lead to various respiratory infections
  3. Staphylococcus aureus: A common bacterium that can cause respiratory infections, especially in people with weakened immune systems
  4. Streptococcus pneumoniae: Also known as pneumococcus, this bacterium is a leading cause of pneumonia and other respiratory infections
These bacteria are included in an inactivated form to stimulate the immune system without causing an actual infection.

How Buccalin Works

Buccalin works as a bacterial vaccine. It contains inactivated forms of bacteria that commonly cause respiratory infections. When you take Buccalin, your immune system is exposed to these bacterial components. This exposure helps your body recognize these bacteria in the future and mount a faster, more effective immune response if you encounter them again. This process, known as immunization, can help prevent future infections or reduce their severity[1].

Administration

Buccalin is taken orally as a gastro-resistant tablet[1]. The maximum daily dose is 31.5 billion organisms, and the maximum total dose over the treatment period is 378 billion organisms[1]. The treatment period can last up to 12 months[1]. Always follow your doctor’s instructions regarding dosage and duration of treatment.

Ongoing Clinical Trial

Buccalin is currently being studied in a clinical trial to confirm and collect more data on its effectiveness and safety[1]. This trial is:

  • Randomized: Participants are randomly assigned to either receive Buccalin or a placebo
  • Double-blind: Neither the participants nor the researchers know who is receiving Buccalin or the placebo
  • Placebo-controlled: Some participants receive a placebo (a substance with no active ingredients) for comparison
  • Multicenter: The study is being conducted at multiple medical centers
The main goal of this study is to see if Buccalin can reduce the number of respiratory infection episodes over a 12-month period compared to a placebo[1].

Potential Benefits

The ongoing clinical trial aims to assess several potential benefits of Buccalin, including[1]:

  • Reduction in the number of respiratory infection episodes
  • Decrease in the duration of respiratory infections
  • Reduction in the need for antibiotic treatments
  • Fewer sick days for patients
  • Improved quality of life (as measured by a Visual Analogue Scale)
However, it’s important to note that these potential benefits are still being studied and are not yet confirmed.

Who Can Use Buccalin?

Based on the clinical trial criteria, Buccalin may be suitable for[1]:

  • Adults aged 18 to 99 years
  • People who have had 2 or more episodes of lower respiratory tract infections within the past 12 months
  • Individuals with documented lower respiratory tract infections confirmed by microbiological tests
The medication may be used in conjunction with various vaccinations, including those for pertussis, COVID-19, respiratory syncytial virus, influenza, and pneumococcal disease[1].

Precautions and Contraindications

Buccalin may not be suitable for everyone. Based on the clinical trial exclusion criteria, it should not be used by[1]:

  • Pregnant or breastfeeding women
  • People with severe liver damage
  • Individuals who have had malignancies (cancers) within the past 5 years
  • Those who have recently used steroids, immunosuppressants, or other bacterial lysates
  • People with certain medical conditions, including pneumonia, tuberculosis, cystic fibrosis, HIV, severe heart failure, and end-stage renal failure
  • Individuals with known hypersensitivity to the ingredients in Buccalin
Always consult with your healthcare provider to determine if Buccalin is appropriate for you, considering your individual health status and medical history.

Aspect Details
Study Type Randomized, double-blind, placebo-controlled, two-arm, multicenter trial
Medication Buccalin® tablets (containing bacterial lysates)
Target Condition Recurrent Lower Respiratory Tract Infections (RLRTIs)
Primary Outcome Reduction in infection episodes over 12 months
Secondary Outcomes Infection duration, antibiotic use, sick days, quality of life
Participant Age Range 18 to 99 years old
Key Inclusion Criteria ≥2 RTI episodes within 12 months, documented by microbiological tests
Key Exclusion Criteria Pregnancy, severe liver damage, recent immunosuppressant use, pneumonia

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to confirm and collect more clinical data on the effectiveness of Buccalin® tablets in preventing recurrent lower respiratory tract infections (RLRTIs) in adults.
  • Who can participate in this study? Adults aged 18 to 99 years old with a history of recurrent lower respiratory tract infections (at least 2 episodes within 12 months) can participate, provided they meet other specific criteria.
  • What is Buccalin® and what does it contain? Buccalin® is a medication in the form of gastro-resistant tablets. It contains bacterial lysates, including Streptococcus agalactiae, Haemophilus influenzae, Staphylococcus aureus, and Streptococcus pneumoniae.
  • How long does the treatment period last in this study? The treatment period in this study lasts for 12 months, with assessments also conducted at 3, 6, and 9 months.
  • What are the main outcomes being measured in this trial? The main outcomes include the reduction in the number of infection episodes, duration of infections, antibiotic use, number of sick days, and patient-reported quality of life using a Visual Analogue Scale. The study also evaluates the safety of the treatment.

Ongoing Clinical Trials on Streptococcus Agalactiae

  • Study on Buccalin for Preventing Recurrent Lower Respiratory Infections in Adults

    Recruiting

    1 1 1
    Investigated drugs:
    Italy

Glossary

  • Recurrent Lower Respiratory Tract Infections (RLRTIs): Repeated infections affecting the lower part of the respiratory system, including the lungs and airways. In this study, it refers to having at least 2 episodes within 12 months.
  • Bacterial lysates: Mixtures of bacterial components used to stimulate the immune system. In Buccalin®, these come from specific bacteria that commonly cause respiratory infections.
  • Gastro-resistant tablet: A type of tablet designed to resist stomach acid and release its contents in the intestines.
  • Placebo: A substance with no active medical ingredients, used as a control in clinical trials to compare against the effects of the actual treatment.
  • Post Authorization Efficacy and Safety Study (PAES): A study conducted after a medication has been approved to gather more information about its effectiveness and safety in real-world use.
  • Visual Analogue Scale (VAS): A measurement tool used to assess a characteristic or attitude that ranges across a continuum of values, typically from 0 to 10.
  • Prophylaxis: Preventive treatment or measures taken to protect against a disease or condition.

References

  1. http://clinicaltrials.eu/trial/study-on-buccalin-for-preventing-recurrent-lower-respiratory-infections-in-adults/