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NCT Number: NCT07184684

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

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.

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Key information

Conditions

Chronic Rhinosinusitis Without Nasal Polyps Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Departement of ORL

Helsingborg, 25187, Sweden

Location status: Recruiting

Location contact

Anders Mårtensson, MD, PhD

CONTACT

[email protected]

+46768617200

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sinonasal microbiome transplant procedure.

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

Other

Placebo transplant containing saline administered as a nasala lavage once daily for five consecutive days.

Primary outcomes

  1. Sino-nasal outcome test 22 (SNOT-22) (min 0 - max 110 higher being worse)

    Time frame: 14 days before intervention, on the first day of intervention, 2 and 3 months after intervention and as a follow up 1, 2 and 3 years after the study.

    Subjective symptom grading of the patients will be used to asses efficacy of the treatment and the duration of the treatment effect.

Secondary outcomes

  1. Endoscopy

    Time frame: 2 weeks before intervention, 3 months after intervention and as a follow up 1, 2 and 3 years after the study.

    Patients will be documented using video endoscopy for later, blinded grading.

  2. Total Nasal Symptom Score. (min 0 - max 9)

    Time frame: 14 days before intervention, daily during the five days of intervention, 2 and 3 months after intervention and as a follow up 1, 2 and 3 years after the study.

    The TNSS scale will be used to measure nasal symptoms of donors and patients especially during the transplant procedure to evaluate the tolerability of the procedure.

  3. Metagenomics

    Time frame: 6 and 2 weeks before intervention, 8 and 12 weeks after intervention and as a follow up twice with 4 weeks apart 1, 2 and 3 years after the study.

    Microbiological samples will be collected from both donors and patients to assess whether the microbiota differ in patients with CRS compared to healthy subjects regarding composition, abundance, diversity, and stability. Further we will examine the effect of the microbiome transplant procedure on the recipients microbiota.

  4. Metabolomics

    Time frame: 2 weeks before intervention and 12 weeks after intervention and as a follow up 1, 2 and 3 years after the study.

    Metabolomics samples will be collected from both donors and patients to assess if the microbiome activity differ in patients with CRS compared to healthy subjects and if this activity is affected by the microbiome transplant procedure.

  5. Inflammatory markers

    Time frame: 2 weeks before intervention, 12 weeks after intervention and as a follow up 1, 2 and 3 years after the study.

    Biopsies from the nasal mucosa will be collected from both donors and patients and analysed for inflammatory endotypes and to assess the effect of the microbiome transplant procedure in the patients.

  6. Adverse events

    Time frame: Entire study duration. Total study duration is 1 year and 5 months for the study and 3 years of follow up.

    Any adverse events reported by the patients will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Anders Mårtensson, MD, PhD

CONTACT

[email protected]

0424061000

Frida Blixt, MD

CONTACT

[email protected]

0424061000

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2031
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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