Sinonasal microbiome transplant for chronic rhinosinusitis

Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS): A Randomized , Placebo Controlled Cross Over Trial

This will try a sinonasal microbiome transplant to see if it reduces symptoms in people with chronic rhinosinusitis with or without nasal polyps.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Region Skane (Academic / other)
• Locations: 1 site (Helsingborg)
• Trial ID: NCT07184684 on ClinicalTrials.gov

What this trial studies

Adults with chronic rhinosinusitis (duration >12 weeks) will receive either a donor-derived sinonasal microbiome transplant or a placebo saline transplant delivered to the nasal cavities. Donors must meet strict health criteria and be accepted by the patient, and participants with recent antibiotics, biologic therapy, pregnancy, or major immunodeficiency are excluded. Outcomes will include symptom scores and objective nasal/sinus findings over follow-up to compare the active transplant versus placebo. The protocol is conducted at the Department of ORL in Helsingborg and spans phase 2 and phase 3 testing.

Who should consider this trial

Good fit: Ideal candidates are adults with physician-verified chronic rhinosinusitis lasting more than 12 weeks, meaningful symptom burden (SNOT-22 ≥20), no recent antibiotic use, and who are willing to accept an approved donor.

Not a fit: Patients who recently took antibiotics, are receiving biologic therapies, have significant immunodeficiency or severe anatomic abnormalities, are pregnant or breastfeeding, or have low symptom scores (SNOT-22 <20) are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the procedure could reduce chronic sinus symptoms and decrease the need for repeated antibiotics or surgery.

How similar studies have performed: The approach is relatively novel for CRS: there are limited pilot and preclinical data suggesting microbiome modulation might help, but large controlled clinical evidence is still sparse.

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.

Where this trial is running

Helsingborg

• Departement of ORL — Helsingborg, Sweden (Recruiting)

Study contacts

• Principal investigator: Anders Mårtensson, MD, PhD — Region Skåne, Lund University
• Study coordinator: Anders Mårtensson, MD, PhD

Conditions Chronic Rhinosinusitis Without Nasal Polyps; Chronic Rhinosinusitis With Nasal Polyps