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Study on Preventing Respiratory Infections and Wheezing in Late-Moderate Preterm Infants Using Bacterial Lysates

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying how to protect infants born a little early, known as moderate-late preterm infants, from getting sick with lower respiratory tract infections and experiencing wheezing during their first year of life. The treatment being tested is a medication called BRONCHO-VAXOM Kinderen, which comes in the form of hard capsules. This medication contains special ingredients known as lyophilized bacterial lysates, which are tiny parts of bacteria that have been dried and are used to help the body’s immune system learn to fight off infections better.

The purpose of the study is to see if giving these bacterial lysates to preterm infants can help reduce the number of respiratory infections and wheezing episodes they experience. The study will involve giving the medication to the infants and observing them over a period of time to see if it helps in reducing these health issues. Some infants will receive the actual medication, while others will receive a placebo, which looks like the medication but does not contain the active ingredients. This helps researchers understand the true effect of the medication.

Throughout the study, researchers will monitor the infants to see how many times they get sick with respiratory infections or wheeze, and how long it takes for these symptoms to appear. They will also look at other factors like the use of additional medications, the infants' lung function, and their overall quality of life. The study aims to provide valuable information on whether this treatment can help improve the health of preterm infants by boosting their immune system early on.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that the gestational age at delivery was between 30 weeks and 35 weeks and 6 days. The postnatal age should be at least 6 weeks, and the postmenstrual age should be at least 37 weeks.

    Both parents or formal caregivers must provide written informed consent for participation in the study.

  2. Step 2

    Medication administration

    The medication used in this study is called Broncho-Vaxom Kinderen, which comes in the form of hard capsules.

    The medication is taken orally. The specific dosage, frequency, and duration of administration will be provided by the study team.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, the total number of physician-diagnosed lower respiratory tract infections (RTI) and wheezing episodes in the first year of life will be recorded.

    The time to the first lower respiratory episode after 12 months of age will also be monitored.

  4. Step 4

    Additional assessments

    Secondary assessments include the time to the first lower RTI or wheezing episode in the first year of life, and the total number of RTI and wheezing episodes in the first and second year of life.

    Other factors such as the distribution of viruses during lower RTI/wheezing, medication use, lung function, quality of life, and any serious adverse events will be evaluated.

  5. Step 5

    End of study

    The study is estimated to end on December 1, 2027.

    At the conclusion of the study, results regarding serum specific IgE (allergen sensitization) and infant vaccination titers at 12 months will be reviewed.

Who can join the trial?

3 criteria

  • Babies born between 30 weeks and 0 days and 35 weeks and 6 days of pregnancy.
  • Babies who are at least 6 weeks old after birth when they join the study and have reached at least 37 weeks of age when counting from the start of the mother's last menstrual period.
  • Both parents or legal caregivers must give their written permission for the baby to join the study.

Who cannot join the trial?

10 criteria

  • Patients with a history of severe allergic reactions to any of the ingredients used in the study.
  • Patients who have received any other investigational drug or treatment within the last 30 days.
  • Patients with any serious medical condition that might interfere with the study, such as uncontrolled diabetes or heart disease.
  • Patients who are currently participating in another clinical trial.
  • Patients with a known immune system disorder, which means their body's defense system is not working properly.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients with a history of chronic lung disease, which is a long-term condition affecting the lungs.
  • Patients who are unable to follow the study procedures or instructions.
  • Patients with a history of premature birth complications that are not related to the study's focus.
  • Patients who have been diagnosed with a condition that affects their ability to breathe normally.
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Investigated drugs

Bacterial Lysates are a type of therapy used in this clinical trial. They are made from broken-down parts of bacteria. The idea is to introduce these bacterial components to the body in a safe way, which helps to train and strengthen the immune system. For preterm infants, whose immune systems are still developing, this therapy aims to provide better protection against infections in the respiratory tract and reduce episodes of wheezing. By regularly exposing the immune system to these bacterial elements, the therapy hopes to speed up the maturation of the immune system, helping these infants to fight off infections more effectively.

What is already known about the treatment

Bacterial Lysates – Bacterial lysates are administered orally, typically in the form of tablets or capsules, and are used to stimulate the immune system. In medical literature, they are being studied for their potential to protect against respiratory infections, particularly in moderate-late premature infants. The main therapeutic indication is to reduce the incidence of lower respiratory tract infections and wheezing in these infants during their first year of life. At the molecular level, bacterial lysates work by exposing the immune system to small, non-infectious parts of bacteria, which helps the body build a stronger defense against future infections. They are classified pharmacologically as immunostimulants.

Investigated diseases

  • Lower respiratory tract infections

    These infections affect the airways and lungs, including conditions like bronchitis and pneumonia. They often begin with symptoms such as coughing, wheezing, and difficulty breathing. As the infection progresses, it can lead to increased mucus production and inflammation in the airways. In severe cases, it may cause significant breathing difficulties and require medical intervention. The progression can vary depending on the individual's immune response and the specific pathogen involved.

  • Wheezing

    Wheezing is a high-pitched whistling sound made while breathing, often associated with difficulty in breathing. It occurs when the airways are narrowed or blocked, commonly due to inflammation or mucus buildup. Wheezing can be a symptom of various respiratory conditions, including asthma and infections. The severity and frequency of wheezing episodes can vary, and they may be triggered by factors such as allergens, infections, or physical activity. As the underlying condition progresses, wheezing may become more frequent or severe.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-518498-32-01Estimated enrolment500 patientsSponsorSint Franciscus Vlietland Groep Stichting

sourced from the EU Clinical Trials Register and site verification

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