Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).
NCT ID: NCT07184684
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
50 participants
INTERVENTIONAL
2024-10-14
2031-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Microbiome transplant
The study subject is examined before and after recieving 13 days of antibiotics followed by 5 concecutive days of microbiome transplant.
Sinonasal microbiome transplant procedure.
A sinonasal microbiome transplant obtained from a healthy donor and administered as a nasal lavage once daily for five consecutive days.
Placebo transplant
The study subject is examined before and after recieving 13 days of antibiotics followed by 5 concecutive days of placebo (saline) transplant.
Placebo saline transplant
Placebo transplant containing saline administered as a nasala lavage once daily for five consecutive days.
Interventions
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Sinonasal microbiome transplant procedure.
A sinonasal microbiome transplant obtained from a healthy donor and administered as a nasal lavage once daily for five consecutive days.
Placebo saline transplant
Placebo transplant containing saline administered as a nasala lavage once daily for five consecutive days.
Eligibility Criteria
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Inclusion Criteria
* Sinusitis verified by endoscopy or CT scan
* Duration \> 12 weeks.
* Signed informed consent to participate in the study.
* 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
* 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.
* 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.
18 Years
ALL
Yes
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Anders Mårtensson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Skåne, Lund University
Locations
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Departement of ORL
Helsingborg, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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Dnr 2024-03308-02
Identifier Type: -
Identifier Source: org_study_id
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