Microbiota transfer to treat chronic sinusitis

SinoNasal Microbiota Transfer (SNMT) to Treat Chronic Rhinosinusitis: A Randomized, Double-blind, Placebo-controlled Trial

This study is testing if a new treatment that involves transferring healthy sinus bacteria can help people with stubborn chronic sinusitis feel better when other treatments haven't worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: St. Paul's Hospital, Canada (Academic / other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT05454072 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of SinoNasal Microbiota Transfer (SNMT) in patients suffering from recalcitrant chronic rhinosinusitis (CRS). The study will involve a randomized, double-blind, placebo-controlled design with 80 participants, where some will receive a healthy sinus microbiota transplant while others will receive a sham treatment. The goal is to determine if this innovative approach can improve symptoms and quality of life for patients who have not responded to traditional treatments. The trial aims to address the underlying microbiota disruptions that may contribute to persistent inflammation in CRS patients.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with recalcitrant chronic rhinosinusitis who have previously undergone sinus surgery and have not improved despite maximal medical treatment.

Not a fit: Patients who do not have chronic rhinosinusitis or those who have not undergone prior sinus surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective treatment option for patients suffering from chronic rhinosinusitis who have not benefited from existing therapies.

How similar studies have performed: While microbiota transfer has shown promise in treating other conditions, this specific approach for chronic rhinosinusitis is novel and has not been extensively tested in previous studies.

Eligibility criteria

Inclusion Criteria for Patients:

* Recalcitrant CRS patients
* Able to provide informed consent
* Diagnosed with CRS (with/without polyps) and have previously undergone functional endoscopic sinus surgery (Post-FESS)
* Continued to fail despite receiving "maximal and adequate medical treatment" This is defined as patients who:
* Have received topical nasal steroids in any form (Spray/ Rinse/ Atomized) for at least 3 months or at least one course of oral corticosteroids treatment (\>0.5 mg/kg for 2 weeks tapering dose);
* Had at least one course of antibiotic treatment either based on culture and sensitivity of nasal sinus secretions or as long-term low dose macrolide therapy (clarithromycin 500mg twice a day for 2 weeks then 250 mg once a day for 4 weeks) for at least one trial or have received a course of itraconazole 100mg twice daily for 6 weeks
* Have deteriorating SNOT-22 Scores (≥20) or do not improve after surgery and appropriate maximal medical management (MLK score ≥ 2, with at least 2 points on the discharge subdomain)

Exclusion Criteria for Patients:

* Diagnosed with sinonasal tumors
* Autoimmune diseases affecting the upper airway (e.g., systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis)
* Immune-compromised patients
* Impairment in mucociliary function (e.g., cystic fibrosis, Kartagener syndrome)
* Pregnant or planning to become pregnant or breastfeeding
* Severe underlying disease with anticipated survival less than 6 months
* Unable to tolerate SNMT for any reason

Inclusion Criteria for Donors:

* 19 years of age or older
* Able to provide informed consent, complete donor screening, and adhere to SNMT mucus collection and testing procedures

Exclusion Criteria for Donors:

* If they are positive for any of the following: (i) from blood or mucus testing, human Immunodeficiency virus (HIV) I/II, hepatitis A IgM, hepatitis B surface antigen (HBsAg), hepatitis C, human T- lymphotropic virus (HTLV) I/II, methicillin-resistant Staphylococcus aureus, multidrug resistant bacteria, and/or SARS-CoV-2
* A history of sinonasal or lower airway disease within the last 2 years other than the common cold; diagnosed with CRS; diagnosed with acute rhinosinusitis within the last six months; asthma; and/or clinical findings of sinonasal disease at the inclusion visit and immunodeficiency; any history of active cancer, or risk factors for acquisition of HIV, syphilis, hepatitis A, hepatitis B, hepatitis C, prion, or relevant neurological disease, receipt of blood transfusion from a country other than Canada in the preceding 6 months, any type of antibiotic treatment or any systemic immunosuppressive agents in the 3 months prior to the donation, or any current or previous medical or psychosocial condition or behaviours, which in the opinion of the investigator, may pose a risk to the recipient or the donor

Where this trial is running

Vancouver, British Columbia

• St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Study coordinator: Amin Javer, MD

Conditions Sinusitis, Chronic; Sinus Disease; Sinus Infection; Sinus Infection Chronic; Microbiota Transplant; Chronic Rhinosinusitis