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Impact of Symbiofilm On Nasal Microbiota

NCT05015530 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2024-11-08

Study results available
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Summary

Healsea® chronic is CE marked medical device indicated in adults for the treatment of nasal symptoms of chronic rhinosinusitis. This is an hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract (0.2%) isolated from marine bacteria. In vitro, Symbiofilm® inhibits at early stage biofilm formation from bacteria found to be more prevalent and abundant in CRS patients (e.g. Staphylococcus aureus, Pseudomonas aeruginosa). This exploratory study is designed with aim to determine if the antibiofilm properties of Symbiofilm® may modify sino-nasal microbiota, impacting α and/ or β diversities.

Conditions

  • Rhinosinusitis Chronic
  • Microbiome

Interventions

DEVICE

Healsea® Chronic, hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract

Healsea® Chronic nasal spray will be administered twice daily (1 puff, 1-2 sec) in each nostril during 30 days

Sponsors & Collaborators

  • Lallemand Pharma AG

    lead INDUSTRY

Principal Investigators

  • Pr Guillaume de Bonnecaze, MD, PhD · Department of Otorhinolaryngology , University Hospital of Toulouse (Larrey), France

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2023-05-19
Completion
2023-05-19

Countries

  • France

Study Locations

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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 NCT05015530 on ClinicalTrials.gov