Sinonasal Microbiota Transfer for Sinus Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
St. Paul's Hospital, Vancouver, Canada
Sinus Infection+7 More
Sinonasal Microbiota Transfer - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Chronic sinusitis (CRS) is a common inflammatory condition of the sinuses that affects up to 2.5% of the Canadian population, and is thought to be caused by bacterial infection, resistant biofilms, chronic inflammation and possibly an unhealthy population of sinus microbes (or microbiota). Symptoms include nasal obstruction and discharge, facial pain, loss of smell and sleep disturbance, which all strongly impact quality of life. CRS treatment involves nasal or oral steroids, repeated rounds of antibiotic, and sinus surgery. Despite maximal treatment, some recalcitrant patients suffer with CRS for years. The lack of new, effective therapies to treat CRS leads the investigators to test whether a SinoNasal Microbiota Transfer (SNMT) could trigger CRS recovery. SNMT is defined as the endoscopic transfer of a healthy sinus microbiota from a fully screened donor's sinus to a CRS patient's sinus(es). Similar to a fecal transplant used to treat Clostridioides difficile diarrhea, the sinonasal microbiota transfer may eliminate sinus pathogens and restore the sinus microbiota to a healthy state. SNMT will be combined with a one-time, high volume, high pressure "sinus power wash" pre-treatment to temporarily clear the way for the donor microbiota to establish itself. The investigators will conduct a proof-of-principle, randomized, double-blind, placebo-controlled trial of 80 subjects to test whether a sinus power wash plus SNMT improves clinical outcomes in CRS patients.

Eligible Conditions

  • Sinus Infection
  • Sinusitis, Chronic
  • Sinus Disease
  • Sinusitis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Baseline to 45 days, 90 days, 180 days

Baseline to 45 days
MLK
Modified Lund-Kennedy (MLK) endoscopic scoring
Day 180
Immune markers
Microbiome
Microbiome analysis of patients and donor samples
SNOT-22
Sinonasal Outcome Test (SNOT-22) questionnaire
Smell Test
Baseline to any time until the end of the study period
Adverse Events
Adverse and serious adverse events

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Sinonasal Microbiota Transfer
1 of 2
Sham Sinonasal Microbiota Transfer
1 of 2
Experimental Treatment
Non-Treatment Group

80 Total Participants · 2 Treatment Groups

Primary Treatment: Sinonasal Microbiota Transfer · Has Placebo Group · N/A

Sinonasal Microbiota Transfer
Procedure
Experimental Group · 1 Intervention: Sinonasal Microbiota Transfer · Intervention Types: Procedure
Sham Sinonasal Microbiota Transfer
Procedure
ShamComparator Group · 1 Intervention: Sham Sinonasal Microbiota Transfer · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 45 days, 90 days, 180 days
Closest Location: St. Paul's Hospital · Vancouver, Canada
Photo of Vancouver 1Photo of Vancouver 2Photo of Vancouver 3
2004First Recorded Clinical Trial
1 TrialsResearching Sinus Infection
199 CompletedClinical Trials

Who is running the clinical trial?

Amin JaverLead Sponsor
Amin Javer, MDStudy DirectorUniversity of British Columbia
5 Previous Clinical Trials
352 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have received at least one course of antibiotic treatment for at least one month or you have received a course of itraconazole for at least 6 weeks.
You have a moderate to severe chronic rhinosinusitis with nasal polyps and have a pre- and post-operative score of 20 or more on the SNOT-22.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.