N/A N=12

Impact of Symbiofilm On Nasal Microbiota

Rhinosinusitis Chronic · Microbiome

Bottom Line

View on ClinicalTrials.gov: NCT05015530 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2024

Primary outcome: Primary: Comparaison of Alpha-diversity of Sino-nasal Microbiota Before and After Treatment (Visit 1 and Visit 2) — 2.041; 2.114 Shannon Index — p=0.908

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Healsea® Chronic, hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lallemand Pharma AG
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Comparaison of Alpha-diversity of Sino-nasal Microbiota Before and After Treatment (Visit 1 and Visit 2)	2.041; 2.114	0.908
SECONDARY Impact of Healsea® Chronic on Quality of Life Assessed by the Sino-Nasal Outcome Test Score-22	59.3; 41.8; 0; -17.5	—
SECONDARY Patient Satisfaction Questionnaire (Usability)	0; 0; 0; 0; 12	—
SECONDARY Patient Satisfaction Questionnaire (Taste)	0; 0; 8; 3; 1	—
SECONDARY Patient Satisfaction Questionnaire (Efficacy)	0; 0; 2; 6; 4	—

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.

Eligibility Criteria

Inclusion Criteria

Male or female, aged 18 - 70 years
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Diagnosed with CRS based on the diagnostic criteria of the EPOS guideline
Registered with a social security scheme or covered by such a regime

Exclusion Criteria

Antibiotics or oral corticosteroids intake in the month prior to the study
Endoscopic sinus surgery in the past 6 months
Cystic fibrosis
Wegener's granulomatosis
Immunodeficiency
Defective access to middle meatus
Lidocaine allergy
Known hypersensitivity/allergy to any component of the test device
Pregnant/Lactating female or absence of efficient contraception
Under tutorship or guardianship

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05015530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.