OM85

Generic Name: OM85

Drug Type: Biotech

Background: OM-85, a bacterial extract, is an immunomodulator of interferon-β production and inflammasome activity.

Clinical Trials

A Study to Assess the Efficacy and Safety of Daily OM-85 in Young Children With Recurrent Wheezing

Phase 2

Recruiting

Conditions: Recurrent Wheezing
Wheezing Lower Respiratory Illness

Interventions: Drug: OM-85
Drug: Placebo

First Posted Date: 2023-05-15

Last Posted Date: 2025-05-11

Lead Sponsor: OM Pharma SA

Target Recruit Count: 288

Registration Number: NCT05857930

Locations: 🇺🇸
Rady Children's Hospital, San Diego, California, United States
🇦🇺
University Hospital Geelong - Barwon Health, Geelong, Victoria, Australia
🇦🇺
The Royal Childrens Hospital, Melbourne, Victoria, Australia

and more 36 locations

OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness

Phase 4

Active, not recruiting

Conditions: Wheezing Lower Respiratory Illness
Respiratory Tract Infections

Interventions: Drug: OM-85
Drug: Placebo

First Posted Date: 2023-01-10

Last Posted Date: 2025-04-04

Lead Sponsor: OM Pharma SA

Target Recruit Count: 525

Registration Number: NCT05677763

Locations: 🇬🇧
Royal London Hospital, London, United Kingdom
🇩🇪
Ludwig Maximilians Universität München, München, Bayern, Germany
🇩🇪
Clinical Research & Healthcare GmbH, Schönau Am Königssee, Bayern, Germany

and more 37 locations

Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD

Phase 2

Terminated

Conditions: Atopic Dermatitis

Interventions: Drug: Broncho-Vaxom
Drug: Placebo

First Posted Date: 2022-02-03

Last Posted Date: 2023-08-08

Lead Sponsor: OM Pharma SA

Target Recruit Count: 63

Registration Number: NCT05222516

Locations: 🇩🇪
Hautarztpraxis Burgstrasse, München, Germany
🇩🇪
MENSINGDERMA research GmbH, Hamburg, Germany
🇫🇷
Centre d'investigation clinique GHE, Bron, France

and more 25 locations

Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

Phase 3

Recruiting

Conditions: Wheezing
LRTI
Premature

Interventions: Drug: Broncho-Vaxom
Other: Placebo

First Posted Date: 2021-09-30

Last Posted Date: 2024-08-22

Lead Sponsor: Franciscus Gasthuis

Target Recruit Count: 500

Registration Number: NCT05063149

Locations: 🇳🇱
Franciscus Gasthuis & Vlietland, Rotterdam, Zuid-Holland, Netherlands

Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome

Not Applicable

Conditions: Nephrotic Syndrome in Children

Interventions: Drug: Broncho-Vaxom

First Posted Date: 2021-09-14

Last Posted Date: 2021-09-14

Lead Sponsor: Fang Deng

Target Recruit Count: 83

Registration Number: NCT05044169

Reducing Acute Severe Respiratory Events in Health Care Workers During the Covid-19 Pandemic With OM85

Phase 3

Completed

Conditions: Respiratory Viral Infection
Covid19

Interventions: Drug: Broncho-Vaxom®

First Posted Date: 2020-08-03

Last Posted Date: 2022-03-09

Lead Sponsor: The University of Queensland

Target Recruit Count: 59

Registration Number: NCT04496245

Locations: 🇦🇺
The Prince Charles Hospital, Brisbane, Queensland, Australia
🇦🇺
The Princess Alexandra Hospital, Brisbane, Queensland, Australia
🇦🇺
Queensland Children's Hospital, South Brisbane, Queensland, Australia

PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study

Phase 2

Active, not recruiting

Conditions: Asthma

Interventions: Drug: Cavosonstat
Drug: Imatinib Mesylate
Drug: MCT
Drug: Broncho-Vaxom
Drug: Clazakizumab
Other: Placebo

First Posted Date: 2019-10-17

Last Posted Date: 2024-07-11

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 395

Registration Number: NCT04129931

Locations: 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
University of California San Diego: Airway Research & Clinical Trials Center, San Diego, California, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 26 locations

Broncho-Vaxom (OM 85 BV) in Children Suffering From Atopic Dermatitis

Phase 3

Completed

Conditions: Atopic Dermatitis

Interventions: Drug: Broncho-Vaxom
Drug: Placebo - Cap

First Posted Date: 2017-02-09

Last Posted Date: 2017-02-09

Lead Sponsor: Vifor Pharma

Target Recruit Count: 179

Registration Number: NCT03047954

Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness

Phase 2

Active, not recruiting

Conditions: Wheezing
Asthma

Interventions: Drug: Broncho-Vaxom (BV)
Other: Placebo

First Posted Date: 2014-05-28

Last Posted Date: 2024-08-29

Lead Sponsor: University of Arizona

Target Recruit Count: 822

Registration Number: NCT02148796

Locations: 🇺🇸
Boston Children's Hospital, Harvard University, Boston, Massachusetts, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Washington University, Saint Louis, Missouri, United States

and more 8 locations

Prevention of OM-85 on Bronchiectasis Exacerbation

Phase 4

Completed

Conditions: Bronchiectasis With Acute Exacerbation

Interventions: Drug: OM-85 BV

First Posted Date: 2013-10-24

Last Posted Date: 2020-04-21

Lead Sponsor: Chinese Academy of Medical Sciences

Target Recruit Count: 196

Registration Number: NCT01968421

Locations: 🇨🇳
Shanghai Tongji University, Shanghai, China
🇨🇳
Peking Union Medical College Hospital, Beijing, China

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