Sinonasal microbiome transplant for chronic rhinosinusitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Departement of ORL
  Helsingborg, Sweden Recruiting

Study contacts

• Principal investigator: Anders Mårtensson, MD, PhD — Region Skåne, Lund University
• Study coordinator: Anders Mårtensson, MD, PhD
• Email: anders.s.martensson@gmail.com
• Phone: 0424061000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Investigating the effects of Dupilumab on nasal barrier function in chronic rhinosinusitis patients

  This study is testing if the medication Dupilumab can improve the nasal barrier function in people with chronic rhinosinusitis, especially those with nasal polyps.

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• Using 3D printing to enhance nasal irrigation for chronic rhinosinusitis

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• Mepolizumab with or without in-office nasal polypectomy for chronic rhinosinusitis with nasal polyps

  This study tests whether adding mepolizumab, alone or with in-office nasal polypectomy, helps adults with chronic rhinosinusitis with nasal polyps who need biologic treatment.

  Recruiting at 7 sites Phase 4 Instituto de Investigación Marqués de Valdecilla · Barakaldo and 6 other locations · NCT07814924

• Tezepelumab for Chinese adults with nasal polyps: a 24-week treatment study

  This trial tests whether tezepelumab can improve nasal polyps and symptoms in Chinese adults with chronic rhinosinusitis with nasal polyps who are starting therapy.

  Recruiting at 34 sites Phase 3 AstraZeneca · Beijing and 33 other locations · NCT07520162

• Reducing how often biologic injections are given for chronic nasal polyps

  This study will test whether spacing out mepolizumab or dupilumab injections to every 6–8 weeks keeps symptoms controlled in adults with partly controlled chronic rhinosinusitis with nasal polyps.

  Recruiting at 3 sites Phase 4 Copenhagen University Hospital, Rigshospitalet · Aalborg and 8 other locations · NCT07187583

• SHR-1905 injection for chronic rhinosinusitis with nasal polyps

  This trial will test whether SHR-1905 injections help adults with chronic rhinosinusitis with nasal polyps reduce polyp size and symptoms compared with placebo.

  Recruiting Phase 3 Guangdong Hengrui Pharmaceutical Co., Ltd · Shanghai, Shanghai Municipality · NCT07132827

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.