Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
Healthy Volunteers
NCT07184684

Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).

Led by Region Skane · Updated on 2025-09-22

50

Participants Needed

1

Research Sites

328 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic rhinosinusitis (CRS) is a disease associated with impaired quality of life and substantial societal costs. Much is still uncertain regarding the underlying etiology of the disease. Current treatment protocols are based on observed effects rather than a mechanistic understanding of the disease and thus patients often report unsatisfactory symptom reduction despite treatment with maximal medical therapy and even surgery. CRS is subgrouped phenotypically based on whether or not polyps are observed. Recently an endotypical differentiation reflecting the underlying inflammatory profile has been recommended as well, especially for research. Increasing interest in the role of the commensal microbiome inflammatory diseases has followed a growing understanding of its profound impact on the human immune system. Current research indicates that instability and dysfunction of the microbiome is linked to inflammatory disease rather than compositional differences. Previous research has shown that microbiome transplants are effective in restoring the commensal microbiome and reducing inflammation in gastrointestinal disease and in a previous pilot study the investigators showed that sinonasal microbiome transplants are feasible and were associated with reduced symptoms in chronic rhinosinusitis without nasal polyps (CRSsNP). This study will examine if the positive effect on patients symptoms observed in a previous pilot study are sustained in a placebo controlled, blinded study. In addition to this the study will also examine any differences in microbiome structure, stability, and function between patients with CRS and healthy donors as well as any correlation to disease phenotype or inflammatory endotype.

CONDITIONS

Official Title

Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Have at least 2 nasal symptoms, including nasal obstruction or discolored discharge
  • Sinusitis confirmed by endoscopy or CT scan
  • Symptoms lasting longer than 12 weeks
  • Signed informed consent to join the study
  • No history of sinonasal or lower airway disease for donors except common cold in last 2 years
  • Donor accepted by the patient and signed informed consent
Not Eligible

You will not qualify if you...

  • Antibiotic treatment within 3 months before the study start
  • Current or recent participation in another clinical trial
  • Use of medications that could unpredictably affect study results
  • Treatment with monoclonal antibodies (biologics)
  • Immunodeficiency except mild MBL deficiency
  • Pregnant or breastfeeding
  • Severe anatomical abnormalities of nasal passages
  • SNOT-22 score below 20
  • Donors with chronic or acute rhinosinusitis in last 2 years
  • Donors with nasal polyps
  • Donor pre-study scan findings that make them unsuitable

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Departement of ORL

Helsingborg, Sweden, 25187

Actively Recruiting

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Research Team

A

Anders Mårtensson, MD, PhD

CONTACT

F

Frida Blixt, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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