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

NCT03047954 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2017-02-09

No results posted yet for this study

Summary

The objective of this pilot double-blind study was to evaluate the efficacy and the safety of Broncho-Vaxom 1 capsule (3.5 mg) per day for 9 months compared to placebo on the evolution of the disease in children suffering from Atopic Dermatitis (AD).

Conditions

Interventions

DRUG

Broncho-Vaxom

BV is an orally administered immunostimulating preparation, which consists of a lyophilised bacterial extract prepared from 8 bacterial species (Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis)

DRUG

Placebo - Cap

Matching Placebo capsule administered

Sponsors & Collaborators

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Yves De Prost, MD · Hopital Necker-Enfants Malades

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2006-12-31
Completion
2006-12-31

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Entities

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 NCT03047954 on ClinicalTrials.gov