Could a daily powder cut wheezing attacks in toddlers?

NCT ID NCT05857930

Disease control Sponsor: OM Pharma SA Source: ClinicalTrials.gov ↗

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

Summary

This study tests whether a daily dose of OM-85, a bacterial extract mixed into food or drink, can reduce wheezing episodes in children aged 6 months to 5 years who have recurrent wheezing. About 296 children will receive either OM-85 or a placebo for 6 months. The goal is to see if OM-85 lowers the number of wheezing attacks and the need for strong medications like steroids.

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 (a bacterial extract taken by mouth daily)
What this could lead to: If it works, this could offer a simple daily treatment to reduce wheezing attacks and the need for steroids in young children.
What could go wrong: This is a mid-stage trial with 296 children, so results are not yet proven. The treatment may not reduce wheezing episodes more than placebo, and side effects are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

296 people

The number who actually took part.

Started

Jun 2023

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 to 72 months

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: Subjects who meet all the following criteria will be included in the study: * Children of either gender, aged between 6 and 72 months (5 years inclusive). * Children with recurrent wheezing: * For ICS/LTRA naïve patients or intermittent users (patients using ICS treatment only during an upper RTI to prevent WE): ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including one that triggered an unscheduled physician visit, in the 12 months prior to enrollment. * For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS OR having triggered an ED visit/hospitalization) OR ≥2 WEs including at least one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy (at current dose or higher). * Up-to-date vaccination status as per applicable State or country Vaccination Requirements for school/day-care entry. * Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures. Note: If a subject is experiencing respiratory symptoms at time of screening, he/she could only be randomized once symptoms have resolved for at least one week. Exclusion Criteria: * Known anatomic alterations of the respiratory tract. * Wheezing documented to be caused by gastroesophageal reflux. * Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis). * Any known autoimmune disease. * Known human immunodeficiency virus (HIV) infection or any known type of congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency). * Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities. * Children born prematurely i.e., before 34 weeks of gestational age. * Children with an abnormally low or high weight for their age and height, if this would not allow safe completion of the clinical study in the opinion of the investigator. * Any known neoplasia or malignancy. * Treatment with the following medications: * Systemic corticosteroids within 4 weeks before study enrollment. * Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment. * Any major surgery within the last 3 months prior to study enrollment or planned during the study duration. * Known allergy or previous intolerance to investigational drug. * Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study. * Other household members have previously been randomized in this clinical study and have not completed their 6-month treatment period. * Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study). * Currently enrolled in or has completed any other investigational device or drug study \<30 days prior to screening or receiving other investigational agent(s). Note: Subjects with past, present, or at risk of COVID-19 should not be excluded from the study.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Respiratory Sounds

As listed by the trial registrant

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

Recurrent wheezing Wheezing lower respiratory illness

Contacts and locations

Locations

ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp.z o. o.

Tarnów, Lesser Poland Voivodeship, 33-100, Poland
Allergy & Asthma Medical Group and Research (AAMGRC) - Allergy, Asthma and Immunology

San Diego, California, 92123, United States
Allergy & Asthma Specialists PSC

Owensboro, Kentucky, 42301, United States
Allergy, Asthma and Clinical Research Center

Oklahoma City, Oklahoma, 73120, United States
American Research Institute, INC

Cutler Bay, Florida, 33157, United States
Aranyklinika Kft.

Szeged, Csongrád megye, 6720, Hungary
Arizona Medical Clinic

Phoenix, Arizona, 85015, United States
Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States
BioMD Clinical Research

Coral Gables, Florida, 33134, United States
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary
Boston Children's Hospital

Boston, Massachusetts, 02115, United States
C & R Research Services USA. Inc

Miami, Florida, 33183, United States
Children's Hospital Colorado - Pediatric Heart Lung Center - Pediatrics

Aurora, Colorado, 80045-7106, United States
Cincinnati Children'S Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States
Helios Clinical Research - Houston

Houston, Texas, 77008, United States
Hoag Health Center Foothill Ranch

Foothill Ranch, California, 92610, United States
Kern Research Inc.

Bakersfield, California, 93301, United States
La Providence Pediatrics Clinic

Houston, Texas, 77071, United States
Monroe Carell Jr. Children's Hospital

Nashville, Tennessee, 37821, United States
NZOZ E-Vita

Bialystok, Podlaskie Voivodeship, 15-879, Poland
Northwell Health/Division of Allergy & Immunology

Great Neck, New York, 11021, United States
Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States
Prime Clinical Research Inc

Mansfield, Texas, 76063, United States
Rady Children's Hospital

San Diego, California, 92123, United States
Riley Children's Health - Pediatrics

Indianapolis, Indiana, 46202, United States
Rush University Medical Center

Chicago, Illinois, 60612, United States
STAAMP Research

San Antonio, Texas, 78229, United States
The Royal Childrens Hospital

Melbourne, Victoria, 3052, Australia
The University of Arizona Medical Center - University Campus

Tucson, Arizona, 85724, United States
The University of Texas Health Science Center at Tyler - Pulmonology

Tyler, Texas, 75708-3154, United States
UCSF Benioff Children's Hospital Oakland Primary Care Clinic

Oakland, California, 94618, United States
UNC Hospitals, The Univ of NC at Chapel Hill

Chapel Hill, North Carolina, 27514, United States
University Hospital Geelong - Barwon Health

Geelong, Victoria, 3220, Australia
University of Wisconsin School of Medicine & Public Health - allergy, Pulmonary, & Critical Care Medicine

Madison, Wisconsin, 53792-9988, United States
Velocity Clinical Research - Binghamton

Binghamton, New York, 13905, United States
Velocity Clinical Research - Lafayette

Lafayette, Louisiana, 70508, United States
Velocity Skierniewice Sp. z o.o.

Skierniewice, Łódź Voivodeship, 96-100, Poland
Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, 74136, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.