Recruiting

A study to evaluate the effectiveness of a drug combination in reducing respiratory tract infections in children aged 3 to 12 years.

Verified siteRegistered drugNo placebo

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What is this trial about?

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

This study aims to evaluate the effectiveness of PMBL in reducing the occurrence of Respiratory Tract Infections, which are illnesses that affect the nose, throat, or lungs. The investigation involves comparing the use of Ismigen, a medication containing several bacteria such as Haemophilus influenzae, Klebsiella pneumoniae, Neisseria catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, and Klebsiella ozaenae, against a placebo. These medications will be administered as sublingual tablets, which are tablets that are placed under the tongue to dissolve.

During the course of the study, participants will be divided into groups to receive either the test medication or the placebo. The observation period includes a treatment phase during the fall and winter months, followed by a period to monitor health after the treatment has ended. The focus is on observing how often these infections occur and the duration of any illnesses experienced during this time.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Treatment period
You will receive either ismigen sublingual tablets or a placebo, which is a substance with no active medicine.
The ismigen sublingual tablets contain 50 mg of specific bacteria components used to help the body, and they are administered by placing them under the tongue.
This treatment period lasts for 3 months.
Step 2
Follow-up period
After the 3-month treatment ends, there is a 4-month follow-up period.
During these 4 months, the number of respiratory tract infections, which are illnesses affecting the nose, throat, or lungs, will be monitored.

Who can join the trial?

8 criteria

Children of both genders between the ages of 3 and 12 years.
Parents or legal guardians must provide written informed consent, which is a signed document showing they agree to let the child participate.
Children who are 7 years of age or older must provide written assent, meaning they personally agree to take part in the study.
The child must show a tendency to get respiratory tract infections, which are illnesses that affect the nose, throat, or lungs, such as common colds or coughs.
The child must not have had a respiratory tract infection in the 15 days before being assigned to a group in the study.
All girls who are able to become pregnant must have a negative pregnancy urine test at the start of the study.
Parents and children must follow rules regarding contraception, which refers to methods used to prevent pregnancy, during the study.
The child must be able to cooperate and show they can correctly use the PMBL® tablet, which is a small pill placed under the tongue.

Who cannot join the trial?

11 criteria

If you have taken bacterial lysates, which are treatments made from killed bacteria used to help the immune system, in the 6 months before starting the study or if you are currently taking them.
If your body temperature is 37.5°C or higher during the first visit.
If you are pregnant or breastfeeding, or if you are sexually active without using hormonal contraception (such as birth control pills), an intrauterine device (a device placed in the uterus to prevent pregnancy), or barrier methods (such as condoms).
If you have a primary or secondary immunodeficiency, which means your body's immune system (the system that fights germs) does not work correctly.
If you have cystic fibrosis, bronchiectasis (a condition where the airways in the lungs are damaged and widened), alpha-1 antitrypsin deficiency (a genetic condition affecting proteins in the blood), malignancy (cancer), endocrinological diseases (disorders related to hormones), or other long-term lung diseases, though people with asthma or allergic rhinitis (hay fever) may still participate.
If you have a known sensitivity or allergy to any of the ingredients in the study medication.
If you have had a major surgery in the 3 months before joining the study or if you have a surgery planned during the study period.
If you have used steroids through an injection or by mouth in the 4 weeks before joining the study.
If you have used immunosuppressants (medicines that lower the immune system), immunostimulants (medicines that increase immune activity), allergen-immunotherapy (allergy shots), or gamma globulins (proteins that help the immune system) in the 6 months before joining the study.
If you are unable to understand or follow the rules of the study or the instructions for taking the medication.
If you are already participating in another interventional clinical study (a medical research test) at the time of your first visit.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Med Polonia Sp. z o.o.
Poznan, Poland
Verified
Medicome Sp. z o.o.
Oświęcim, Poland

Trial locations

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Investigated drugs

Ismigen is a sublingual tablet, which means it is placed under the tongue to dissolve. This product contains inactivated components from several different types of bacteria that commonly cause respiratory infections. It is used in this study to see if it can help prevent children from getting respiratory tract infections.

What is already known about the treatment

PLACEBO
This is an inactive substance administered as a sublingual tablet that dissolves under the tongue. It is used in clinical trials as a control to compare against the active treatment to ensure results are accurate. This substance contains no medicinal ingredients and has no biological effect on the body.
ISMIGEN
This medication is administered as a tablet placed under the tongue to be dissolved. It is a bacterial vaccine used to help prevent various respiratory tract infections in children. It works by introducing inactivated components of specific bacteria to the body, which teaches the immune system to recognize and fight these germs more effectively.

Investigated diseases

Respiratory Tract Infections - These are illnesses caused by germs that affect the nose, throat, or lungs. They often start with symptoms like coughing, a runny nose, or a sore throat. The infection can stay in the upper respiratory system or move deeper into the chest. As the condition progresses, it may lead to increased mucus production or difficulty breathing. The symptoms vary depending on which part of the respiratory system is affected.