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New hope for wheezy tots: daily pill may cut infections

NCT ID NCT05677763

Prevention Sponsor: OM Pharma SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 04, 2026 · Updated 3 times

Summary

This study tests whether OM-85 (Broncho-Vaxom), a bacterial extract taken by mouth for 10 days each month, can reduce the number of respiratory infections in children aged 6 months to 5 years who have a history of wheezing. About 525 children will receive either OM-85 or a placebo. The main goal is to see if the treatment lowers infection rates and wheezing episodes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OM-85 (Broncho-Vaxom), a bacterial extract taken by mouth
What this could lead to
If it works, this could give doctors a way to reduce the number of respiratory infections and wheezing episodes in young children, potentially lowering hospital visits.
What could go wrong
This is a phase 4 trial, so the drug is already approved, but results may show no benefit over placebo. The effect may vary by child age and health history.

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

525 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Sep 2026

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

6 months to 5 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Children of either gender aged between 6 months and 5 years, at Baseline/Randomisation (Visit 2) inclusive. * For children ≥1 year of age, ≥4 RTIs (as reported by parents or LAR of subject), including ≥2 episodes of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 12 months prior to enrolment. OR * For children \<1 year of age, ≥2 RTIs (as reported by parents or LAR of subject), including ≥1 episode of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 6 months prior to enrolment. * Parents or LAR of subject have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures. Exclusion Criteria: * Anatomic alterations of the respiratory tract. * Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis). * Any autoimmune disease. * HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency). * Known severe congenital heart disease. * Haematologic diseases. * Liver or kidney failure. * New-borns before 34 weeks of gestational age. * Malnutrition as per World Health Organization (WHO) definition. * Any known neoplasia or malignancy. * 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, or gamma globulins within 6 months prior to study enrolment. * Previous use within last 6 months of enrolment or ongoing use of bacterial lysates. * Any major surgery within the last 3 months prior to study enrolment. * Known allergy or previous intolerance to investigational medicinal products (IMP). * Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study. * Other household members have previously been randomised in this clinical study. * Subjects' families expected to relocate out of study area within 24 months of the initiation of the study. * Currently enrolled in or has completed any other investigational device or drug study or receiving other investigational agent(s) within \<30 days prior to screening. * Parents or legally acceptable representative (LAR) who do not have access to internet connection. * Wheezing documented to be caused by gastroesophageal reflux.

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Conditions

The condition(s) this trial relates to.

bronchiolitis respiratory tract infectious disorder prevention target

As listed by the trial registrant

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

Respiratory tract infections Wheezing lower respiratory illness

Contacts and locations

Locations

  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • ASST Papa GiovanniXXIII,Mat.Inf.Ped

    Bergamo, 24127, Italy

  • Aranyklinika Kft

    Szeged, Csongrád megye, 6720, Hungary

  • Azienda ospedalo universitaria

    Parma, Parma, 43100, Italy

  • Brighton And Sussex University Hospitals NHS Trust

    Brighton, East Sussex, BN2 5BE, United Kingdom

  • CHUV-Centre Hopitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

    Lublin, Lublin Voivodeship, 20-552, Poland

  • Centrum Medyczne PROMED

    Krakow, 31-411, Poland

  • Centrum Medyczne Pratia Czestochowa

    Częstochowa, Silesian Voivodeship, 42-217, Poland

  • Clinical Research & Healthcare GmbH

    Schönau am Königssee, Bavaria, 83471, Germany

  • Dr. Kenessey Albert Korhaz-Rendelointezet

    Balassagyarmat, H-2660, Hungary

  • Ev. Krankenhaus Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40217, Germany

  • Futurenest Kft.

    Miskolc, 3527, Hungary

  • Heim Pal Orszagos Gyermekgyogyaszati Intezet

    Budapest, 1089, Hungary

  • Hôpitaux Universitaires de Genève (HUG)

    Geneva, 1205, Switzerland

  • Inselspital Bern Kinderklinik

    Bern, Canton of Bern, 3010, Switzerland

  • King's College Hospital

    London, SE5 9RS, United Kingdom

  • Ludwig Maximilians Universität München

    München, Bavaria, 80337, Germany

  • Malopolskie Centrum Alergologii

    Krakow, Lesser Poland Voivodeship, 31-624, Poland

  • Marien-Hospital Wesel gGmbH

    Wesel, North Rhine-Westphalia, 46483, Germany

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625, Germany

  • NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.

    Skarżysko-Kamienna, Świętokrzyskie Voivodeship, 26-110, Poland

  • NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska

    Siemianowice Śląskie, Silesian Voivodeship, 41-103, Poland

  • NZOZ E-Vita

    Bialystok, Podlaskie Voivodeship, 15-879, Poland

  • Nottingham University Hospitals NHS Trust - Queen's Medical Centre

    Nottingham, Nottingham, NG7 2UH, United Kingdom

  • Osp.Pediatr.Giov.XXIII,AOUC P.Bari

    Bari, 70126, Italy

  • Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o.

    Rzeszów, 35-612, Poland

  • Praxis Köllges

    Mönchengladbach, North Rhine-Westphalia, 41236, Germany

  • Przychodnia Specjalistyczna Prosen-Med NZOZ

    Warsaw, 01-231, Poland

  • Royal Hospital for Children and Young People

    Edinburgh, EH9 1LF, United Kingdom

  • Royal London Hospital

    London, E1 4NS, United Kingdom

  • Royal Manchester Children's Hospital - Paediatrics - Paediatrics

    Manchester, Manchester, M13 9WL, United Kingdom

  • SO S.Chiara, AOU Pisana

    Pisa, Pisa, 56126, Italy

  • Sanitas Diagnosztikai és Rehabilitációs Központ

    Gyula, 5700, Hungary

  • Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika

    Budapest, 1083, Hungary

  • St. Josef-Hospital

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Universita degli Studi di Pavia - Fondazione IRCCS Policlini

    Pavia, Pavia, 27100, Italy

  • Universitaets-Kinderklinik - Kinderspital Zuerich

    Zurich, 8032, Switzerland

  • University Hospital Cologne AöR

    Cologne, North Rhine-Westphalia, 50937, Germany

  • Universitätsklinikum Schleswig-Holstein Campus Lübeck

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Velocity Skierniewice Sp. z o.o.

    Skierniewice, 96-100, Poland

  • WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka

    Lodz, Lódzkie, 90-329, Poland

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