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New hope for wheezy tots: daily pill may cut infections

NCT ID NCT05677763

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

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.

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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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