Status:
RECRUITING
Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).
Lead Sponsor:
Region Skane
Conditions:
Chronic Rhinosinusitis Without Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 tre...
Eligibility Criteria
Inclusion
- Inclusion Criteria (CRS-Patients):
- 2 nasal symptoms, 1 of which must be nasal obstruction or discolored discharge.
- Sinusitis verified by endoscopy or CT scan
- Duration \> 12 weeks.
- Signed informed consent to participate in the study.
- Exclusion Criteria (CRS-Patients):
- Antibiotic treatment in the last 3 months before study start.
- Ongoing or recent participation in another clinical trial.
- Any medication that might affect the results in an unpredictable manner.
- Treatment with monoclonal antibodies (biologics).
- Immunodeficiency other than low grade MBL deficiency.
- Pregnancy or breastfeeding
- Severe anatomical abnormalities.
- SNOT 22 \< 20.
- Inclusion Criteria (Donors):
- No history of sinonasal or lower airway disease within the last two years other than the common cold.
- Accepted as a donor by the patient.
- Signed informed consent to participate in the study.
- Exclusion Criteria (CRS-Patients):
- Chronic rhinosinusitis.
- Acute rhinosinusitis within the last two years.
- Nasal polyposis
- Antibiotic treatment within the last 3 months before the study start.
- On going or recent participation in another clinical trial.
- Findings in the pre study scan that makes the donor unsuitable.
Exclusion
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07184684
Start Date
October 14 2024
End Date
February 1 2031
Last Update
September 22 2025
Active Locations (1)
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1
Departement of ORL
Helsingborg, Sweden, 25187