MedTrace Logo

Effect of Bacterial Lysate on Nasal Carriage of Staphylococcus Aureus

NCT04637425 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-04-11

No results posted yet for this study

Summary

This study assesses the effectiveness of Polyvalent Mechanical Bacterial Lysate (PMBL-Ismigen) in reducing nasal methicillin-resistant Staphylococcus aureus (MRSA) colony growth in children with pollen allergic rhinitis (AR) aged 5 to 17. Half of the participants received PMBL and the other half received a placebo.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

Ismigen

Sublingual tablets containing 7 mg of bacterial lysate from the following bacteria: Staphylococcus aureus, Haemophilus influenzae serotype B, Klebsiella pneumoniae, Klebsiella ozaenae, Neiserria catarrhalis, Streptococcus viridans, Streptococcus pyogenes, Streptococcus pneumoniae (6 strains: TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24) - sublingual use 1 tablet per day over 10 days for 3 successive months.

DRUG

Placebo

Matched tablets without any active substance.

Sponsors & Collaborators

  • Medical University of Lublin

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-22
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT04637425 on ClinicalTrials.gov