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

NCT05222516 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-08-08

No results posted yet for this study

Summary

Clinical data suggest that treatment with OM-85, by inducing an early contact with bacterial extracts, could modulate the immunity of children with Atopic Dermatitis, and thus play an active role in the treatment of Atopic Dermatitis.

The present trial will investigate the influence of administration of OM-85 in the paediatric population younger than 24 months with moderate atopic dermatitis.

The efficacy and safety of OM-85 will be evaluated in children aged 3 to 24 months old with moderate Atopic Dermatitis who may benefit from treatment with OM-85. The placebo treatment period will serve as a reference and has been added to establish efficacy and safety.

Conditions

Interventions

DRUG

Broncho-Vaxom

Daily administration of Broncho-Vaxom 3.5mg capsules

DRUG

Placebo

Daily administration of Placebo capsules

Sponsors & Collaborators

  • OM Pharma SA

    lead INDUSTRY

Principal Investigators

  • Franziska Rueff, Professor · Universitätsklinikum München

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-20
Primary Completion
2023-07-13
Completion
2023-07-13

Countries

  • France
  • Germany
  • Netherlands
  • Poland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05222516 on ClinicalTrials.gov