NCT07184684 Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).
| NCT ID | NCT07184684 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Region Skane |
| Condition | Chronic Rhinosinusitis Without Nasal Polyps |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2024-10-14 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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.
Contact & Investigator
Anders Mårtensson, MD, PhD
PRINCIPAL INVESTIGATOR
Region Skåne, Lund University
Frequently Asked Questions
Who can join the NCT07184684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Rhinosinusitis Without Nasal Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07184684 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07184684 currently recruiting?
Yes, NCT07184684 is actively recruiting participants. Contact the research team at anders.s.martensson@gmail.com for enrollment information.
Where is the NCT07184684 trial being conducted?
This trial is being conducted at Helsingborg, Sweden.
Who is sponsoring the NCT07184684 clinical trial?
NCT07184684 is sponsored by Region Skane. The principal investigator is Anders Mårtensson, MD, PhD at Region Skåne, Lund University. The trial plans to enroll 50 participants.