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Microbiota Transfer for Chronic Rhinosinusitis

NCT05454072 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-23

No results posted yet for this 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.

Conditions

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

Interventions

PROCEDURE

Sinonasal Microbiota Transfer

Pre-screened donor mucus, up to 15mL, will be transplanted into each diseased sinus via nasal lavage.

PROCEDURE

Sham Sinonasal Microbiota Transfer

Saline, up to 15mL, will be transplanted into each diseased sinus via nasal lavage.

Sponsors & Collaborators

  • Amin Javer

    lead OTHER

Principal Investigators

  • Amin Javer, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-15
Primary Completion
2024-04-14
Completion
2026-06-30

Countries

  • Canada

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 NCT05454072 on ClinicalTrials.gov