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New study tests Under-the-Tongue tablet to ward off Kids' winter colds

NCT ID NCT07578012

Prevention Sponsor: Lallemand Pharma AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests whether PMBL® sublingual tablets can reduce the number of respiratory infections (like colds) in children aged 3 to 12 who are prone to getting sick. Half the children will receive the active tablet, and half will receive a placebo (inactive tablet) for 3 months, with 4 more months of follow-up. The goal is to see if the treatment lowers infection rates and antibiotic use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 224 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Children of both genders aged from 3 to 12 years. 2. Written informed consent obtained from the parents/legally authorized representatives 3. Written assent obtained from the subject from 7 years 4. Subject presenting with a susceptibility to respiratory tract infections according to the investigator 5. No respiratory tract infection within 15 days before the randomization visit 6. All girls of childbearing potential have a negative pregnancy urine testing at randomization visit and are informed and their parents as well of the requirement for contraception during the study. 7. A cooperative attitude and ability to correct use of PMBL® tablet. Exclusion Criteria: 1. Subject treated with bacterial lysates within the previous 6 months prior to V1 or ongoing treatment. 2. Body temperature ≥ 37.5°C at the randomization visit. 3. Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods. 4. Primary or secondary immunodeficiency, cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, malignancy, endocrinological diseases or other chronic respiratory diseases, except asthma and allergic rhinitis. 5. Known sensitivity to the components of study medication. 6. Any major surgery within the last 3 months prior to study enrolment or planned to occur within the duration of study. 7. Treatment with the following medications: 1. Injection or oral administration of steroids within 4 weeks prior to study enrolment. 2. Previous and/or concomitant immunosuppressants, immunostimulants, allergen-immunotherapy or gamma globulins within 6 months prior to study enrolment. 8. Inability to understand or comply with study procedures or with study treatment intake. 9. Subject participating in another interventional clinical study at the time of screening visit.

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Conditions

The condition(s) this trial relates to.

respiratory tract infectious disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy children Respiratory tract infections (RTI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alergo-Med Specjalistyczna Przychodnia

    RECRUITING

    Tarnów, Poland

  • Allergotest

    RECRUITING

    Lublin, Poland

  • Bio Zdrowie

    RECRUITING

    Bialystok, Poland

  • Centrum Nowoczesnych Terapii

    RECRUITING

    Krakow, Poland

  • Comarch Healthcare S.A.

    NOT_YET_RECRUITING

    Krakow, Poland

  • In Vivo Sp. z o.o.

    RECRUITING

    Bydgoszcz, Poland

  • Linden Sp. z o.o. sp.k.

    RECRUITING

    Krakow, Poland

  • Med - Polonia

    RECRUITING

    Poznan, Poland

  • Medicome Sp. z o.o.

    RECRUITING

    Oświęcim, Poland

  • Vitamed

    RECRUITING

    Bydgoszcz, Poland

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