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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllRegion Skane
NCT07184684 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Sinonasal microbiome transplant procedure.
  • Placebo saline transplant
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Where

1 site
Departement of ORL
Helsingborg, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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