Impact of Symbiofilm On Nasal Microbiota

NCT05015530 | Completed Results

• 1 other identifier: LPH-2102
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Rhinosinusitis chronic; Adult; Biofilm; 16S rRNA sequencing; Nasal spray; Microbiome

Outcome Measures

Primary Outcomes (1)

• Comparaison of Alpha-diversity of Sino-nasal Microbiota Before and After Treatment (Visit 1 and Visit 2)

  Comparaison of the values of alpha diversity of bacterial species assessed by the Shannon index at baseline and after the treatment period

  At baseline (V1) and at end of the 30-day treatment period (V2)

Secondary Outcomes (4)

• Impact of Healsea® Chronic on Quality of Life Assessed by the Sino-Nasal Outcome Test Score-22

  End of treatment (Visit 2(V2)-Day 30) versus screening/inclusion (Visit 1(V1)-Day 1)

• Patient Satisfaction Questionnaire (Usability)

  Visit 2(V2)-Day 30 (end of treatment)

• Patient Satisfaction Questionnaire (Taste)

  Visit 2(V2)-Day 30 (end of treatment)

• Patient Satisfaction Questionnaire (Efficacy)

  Visit 2(V2)-Day 30 (end of treatment)

Other Outcomes (1)

• Reporting of Adverse Events, Incidents and Expected Side Effects

  During the intervention, up to 30 days

Study Arms (1)

Test Medical Device

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

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

Interventions

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

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

Test Medical Device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects will be recruited by the site among outpatients coming for routine consultation because of CRS.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lallemand Pharma AG: lead

Study Sites (1)

Larrey Hospital

Toulouse, 31400, France

Location

Related Publications (11)

• Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.

  PMID: 32077450 BACKGROUND

• Sivasubramaniam R, Douglas R. The microbiome and chronic rhinosinusitis. World J Otorhinolaryngol Head Neck Surg. 2018 Oct 31;4(3):216-221. doi: 10.1016/j.wjorl.2018.08.004. eCollection 2018 Sep.

  PMID: 30506054 BACKGROUND

• Boase S, Foreman A, Cleland E, Tan L, Melton-Kreft R, Pant H, Hu FZ, Ehrlich GD, Wormald PJ. The microbiome of chronic rhinosinusitis: culture, molecular diagnostics and biofilm detection. BMC Infect Dis. 2013 May 8;13:210. doi: 10.1186/1471-2334-13-210.

  PMID: 23656607 BACKGROUND

• Ramakrishnan VR, Hauser LJ, Frank DN. The sinonasal bacterial microbiome in health and disease. Curr Opin Otolaryngol Head Neck Surg. 2016 Feb;24(1):20-5. doi: 10.1097/MOO.0000000000000221.

  PMID: 26575518 BACKGROUND

• Hoggard M, Wagner Mackenzie B, Jain R, Taylor MW, Biswas K, Douglas RG. Chronic Rhinosinusitis and the Evolving Understanding of Microbial Ecology in Chronic Inflammatory Mucosal Disease. Clin Microbiol Rev. 2017 Jan;30(1):321-348. doi: 10.1128/CMR.00060-16.

  PMID: 27903594 BACKGROUND

• Koeller K, Herlemann DPR, Schuldt T, Ovari A, Guder E, Podbielski A, Kreikemeyer B, Olzowy B. Microbiome and Culture Based Analysis of Chronic Rhinosinusitis Compared to Healthy Sinus Mucosa. Front Microbiol. 2018 Apr 17;9:643. doi: 10.3389/fmicb.2018.00643. eCollection 2018.

  PMID: 29755418 BACKGROUND

• Fastenberg JH, Hsueh WD, Mustafa A, Akbar NA, Abuzeid WM. Biofilms in chronic rhinosinusitis: Pathophysiology and therapeutic strategies. World J Otorhinolaryngol Head Neck Surg. 2016 May 5;2(4):219-229. doi: 10.1016/j.wjorl.2016.03.002. eCollection 2016 Dec.

  PMID: 29204570 BACKGROUND

• Chong LY, Head K, Hopkins C, Philpott C, Glew S, Scadding G, Burton MJ, Schilder AG. Saline irrigation for chronic rhinosinusitis. Cochrane Database Syst Rev. 2016 Apr 26;4(4):CD011995. doi: 10.1002/14651858.CD011995.pub2.

  PMID: 27115216 BACKGROUND

• O'Toole GA. Microtiter dish biofilm formation assay. J Vis Exp. 2011 Jan 30;(47):2437. doi: 10.3791/2437.

  PMID: 21307833 BACKGROUND

• Liu CM, Kohanski MA, Mendiola M, Soldanova K, Dwan MG, Lester R, Nordstrom L, Price LB, Lane AP. Impact of saline irrigation and topical corticosteroids on the postsurgical sinonasal microbiota. Int Forum Allergy Rhinol. 2015 Mar;5(3):185-90. doi: 10.1002/alr.21467. Epub 2014 Dec 29.

  PMID: 25556553 BACKGROUND

• Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. 2009 Oct;34(5):447-54. doi: 10.1111/j.1749-4486.2009.01995.x.

  PMID: 19793277 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Middle meatus swabs dedicated to nasal DNA extraction from microbiota

Limitations and Caveats

Small number of subjects (12 VS 20 expected)

Results Point of Contact

• Title: Dr Bernard Gout
• Organization: BG ClinicalS

b.gout@bgclinicals.com

+33 (0)561 531 944

Study Officials

• Pr Guillaume de Bonnecaze, MD, PhD

  Department of Otorhinolaryngology , University Hospital of Toulouse (Larrey), France

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 20, 2021
• Study Start: December 12, 2022
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: November 8, 2024
• Results First Posted: November 8, 2024

Record last verified: 2023-03

Locations

FR (1)