Chronic Rhinosinusitis Without Nasal PolypsPhase 2/3NCT07184684
Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).
A Phase 2/3 study testing Sinonasal microbiome transplant procedure. in people with Chronic Rhinosinusitis Without Nasal Polyps and Chronic Rhinosinusitis With Nasal Polyps, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis Without Nasal Polyps, Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Sinonasal microbiome transplant procedure.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 14 Oct 2024to Feb 2031
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Departement of ORL
Helsingborg, 25187
Anders Mårtensson, MD, PhD, +46768617200, anders.s.martensson@gmail.com
About this study
Official title: Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS): A Randomized , Placebo Controlled Cross Over Trial
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.
Read more
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.
- Being tested
- Sinonasal microbiome transplant procedure., Placebo saline transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinonasal microbiome transplant procedure.Procedure or surgery
A sinonasal microbiome transplant obtained from a healthy donor and administered as a nasal lavage once daily for five consecutive days.
Placebo saline transplantOther
Placebo transplant containing saline administered as a nasala lavage once daily for five consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Microbiome transplant | Active comparator | The study subject is examined before and after recieving 13 days of antibiotics followed by 5 concecutive days of microbiome transplant. Receives: Procedure: Sinonasal microbiome transplant procedure. |
| Placebo transplant | Placebo comparator | The study subject is examined before and after recieving 13 days of antibiotics followed by 5 concecutive days of placebo (saline) transplant. Receives: Other: Placebo saline transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sino-nasal outcome test 22 (SNOT-22) (min 0 - max 110 higher being worse)
Subjective symptom grading of the patients will be used to asses efficacy of the treatment and the duration of the treatment effect.
Measured: 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.
Secondary outcomes (6)
Endoscopy
Patients will be documented using video endoscopy for later, blinded grading.
Measured: 2 weeks before intervention, 3 months after intervention and as a follow up 1, 2 and 3 years after the study.
Total Nasal Symptom Score. (min 0 - max 9)
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.
Measured: 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.
Metagenomics
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.
Measured: 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.
Metabolomics
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.
Measured: 2 weeks before intervention and 12 weeks after intervention and as a follow up 1, 2 and 3 years after the study.
Inflammatory markers
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.
Measured: 2 weeks before intervention, 12 weeks after intervention and as a follow up 1, 2 and 3 years after the study.
Adverse events
Any adverse events reported by the patients will be recorded.
Measured: Entire study duration. Total study duration is 1 year and 5 months for the study and 3 years of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start14 Oct 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis Without Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- All participants will run through the study twice with a 7 month wash-out in between. Once the participant will run through the microbiome translant arm and once through the placebo arm.. Participants and investigators will be blinded to the if the participant gets microbiome transplantation or placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Mårtensson, MD, PhD, Principal investigator, Region Skåne, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184684
- Sponsor's protocol ID
- Dnr 2024-03308-02
- Status last verified
- Sep 2025
- First submitted
- 12 Jul 2024
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be presented on group level.
Publications
Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
PubMed 32077450Rudmik L, Smith TL. Quality of life in patients with chronic rhinosinusitis. Curr Allergy Asthma Rep. 2011 Jun;11(3):247-52. doi: 10.1007/s11882-010-0175-2.
PubMed 21234819Wahid NW, Smith R, Clark A, Salam M, Philpott CM. The socioeconomic cost of chronic rhinosinusitis study. Rhinology. 2020 Apr 1;58(2):112-125. doi: 10.4193/Rhin19.424.
PubMed 32172284McCormick JP, Thompson HM, Cho DY, Woodworth BA, Grayson JW. Phenotypes in Chronic Rhinosinusitis. Curr Allergy Asthma Rep. 2020 May 19;20(7):20. doi: 10.1007/s11882-020-00916-6.
PubMed 32430653Kato A, Peters AT, Stevens WW, Schleimer RP, Tan BK, Kern RC. Endotypes of chronic rhinosinusitis: Relationships to disease phenotypes, pathogenesis, clinical findings, and treatment approaches. Allergy. 2022 Mar;77(3):812-826. doi: 10.1111/all.15074. Epub 2021 Sep 15.
PubMed 34473358Stevens WW, Peters AT, Tan BK, Klingler AI, Poposki JA, Hulse KE, Grammer LC, Welch KC, Smith SS, Conley DB, Kern RC, Schleimer RP, Kato A. Associations Between Inflammatory Endotypes and Clinical Presentations in Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2812-2820.e3. doi: 10.1016/j.jaip.2019.05.009. Epub 2019 May 22.
PubMed 31128376Foster KR, Schluter J, Coyte KZ, Rakoff-Nahoum S. The evolution of the host microbiome as an ecosystem on a leash. Nature. 2017 Aug 2;548(7665):43-51. doi: 10.1038/nature23292.
PubMed 28770836Belkaid Y, Hand TW. Role of the microbiota in immunity and inflammation. Cell. 2014 Mar 27;157(1):121-41. doi: 10.1016/j.cell.2014.03.011.
PubMed 24679531Martens K, Pugin B, De Boeck I, Spacova I, Steelant B, Seys SF, Lebeer S, Hellings PW. Probiotics for the airways: Potential to improve epithelial and immune homeostasis. Allergy. 2018 Oct;73(10):1954-1963. doi: 10.1111/all.13495. Epub 2018 Jun 28.
PubMed 29869783Aggarwal N, Kitano S, Puah GRY, Kittelmann S, Hwang IY, Chang MW. Microbiome and Human Health: Current Understanding, Engineering, and Enabling Technologies. Chem Rev. 2023 Jan 11;123(1):31-72. doi: 10.1021/acs.chemrev.2c00431. Epub 2022 Nov 1.
PubMed 36317983Psaltis AJ, Mackenzie BW, Cope EK, Ramakrishnan VR. Unraveling the role of the microbiome in chronic rhinosinusitis. J Allergy Clin Immunol. 2022 May;149(5):1513-1521. doi: 10.1016/j.jaci.2022.02.022. Epub 2022 Mar 14.
PubMed 35300985Paramasivan S, Bassiouni A, Shiffer A, Dillon MR, Cope EK, Cooksley C, Ramezanpour M, Moraitis S, Ali MJ, Bleier B, Callejas C, Cornet ME, Douglas RG, Dutra D, Georgalas C, Harvey RJ, Hwang PH, Luong AU, Schlosser RJ, Tantilipikorn P, Tewfik MA, Vreugde S, Wormald PJ, Caporaso JG, Psaltis AJ. The international sinonasal microbiome study: A multicentre, multinational characterization of sinonasal bacterial ecology. Allergy. 2020 Aug;75(8):2037-2049. doi: 10.1111/all.14276. Epub 2020 Mar 30.
PubMed 32167574van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.
PubMed 23323867Wang ZK, Yang YS, Chen Y, Yuan J, Sun G, Peng LH. Intestinal microbiota pathogenesis and fecal microbiota transplantation for inflammatory bowel disease. World J Gastroenterol. 2014 Oct 28;20(40):14805-20. doi: 10.3748/wjg.v20.i40.14805.
PubMed 25356041Martensson A, Cervin-Hoberg C, Huygens F, Lindstedt M, Sakellariou C, Greiff L, Cervin A. Upper airway microbiome transplantation for patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2023 Jun;13(6):979-988. doi: 10.1002/alr.23122. Epub 2023 Jan 1.
PubMed 36515012
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS): A Randomized , Placebo Controlled Cross Over Trial
- ClinicalTrials.gov ID
- NCT07184684
- Acronym / sponsor ID
- Dnr 2024-03308-02
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 22 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- All participants will run through the study twice with a 7 month wash-out in between. Once the participant will run through the microbiome translant arm and once through the placebo arm.. Participants and investigators will be blinded to the if the participant gets microbiome transplantation or placebo.
| Arm | Type | Receives |
|---|---|---|
| Microbiome transplant | Active comparator | Procedure: Sinonasal microbiome transplant procedure.The study subject is examined before and after recieving 13 days of antibiotics followed by 5 concecutive days of microbiome transplant. |
| Placebo transplant | Placebo comparator | Other: Placebo saline transplantThe study subject is examined before and after recieving 13 days of antibiotics followed by 5 concecutive days of placebo (saline) transplant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- No history of sinonasal or lower airway disease within the last two years other than the common cold.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Microbiome transplant |
| Placebo saline transplantPlacebo transplant containing saline administered as a nasala lavage once daily for five consecutive days. | Other | Placebo transplant |
Primary outcome
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.
6 secondary outcomes
Endoscopy
Time frame: 2 weeks before intervention, 3 months after intervention and as a follow up 1, 2 and 3 years after the study.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Background: PubMed 32077450Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.
- Background: PubMed 21234819Rudmik L, Smith TL. Quality of life in patients with chronic rhinosinusitis. Curr Allergy Asthma Rep. 2011 Jun;11(3):247-52. doi: 10.1007/s11882-010-0175-2.
- Background: PubMed 32172284Wahid NW, Smith R, Clark A, Salam M, Philpott CM. The socioeconomic cost of chronic rhinosinusitis study. Rhinology. 2020 Apr 1;58(2):112-125. doi: 10.4193/Rhin19.424.
- Background: PubMed 32430653McCormick JP, Thompson HM, Cho DY, Woodworth BA, Grayson JW. Phenotypes in Chronic Rhinosinusitis. Curr Allergy Asthma Rep. 2020 May 19;20(7):20. doi: 10.1007/s11882-020-00916-6.
- Background: PubMed 34473358Kato A, Peters AT, Stevens WW, Schleimer RP, Tan BK, Kern RC. Endotypes of chronic rhinosinusitis: Relationships to disease phenotypes, pathogenesis, clinical findings, and treatment approaches. Allergy. 2022 Mar;77(3):812-826. doi: 10.1111/all.15074. Epub 2021 Sep 15.
- Background: PubMed 31128376Stevens WW, Peters AT, Tan BK, Klingler AI, Poposki JA, Hulse KE, Grammer LC, Welch KC, Smith SS, Conley DB, Kern RC, Schleimer RP, Kato A. Associations Between Inflammatory Endotypes and Clinical Presentations in Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2019 Nov-Dec;7(8):2812-2820.e3. doi: 10.1016/j.jaip.2019.05.009. Epub 2019 May 22.
- Background: PubMed 28770836Foster KR, Schluter J, Coyte KZ, Rakoff-Nahoum S. The evolution of the host microbiome as an ecosystem on a leash. Nature. 2017 Aug 2;548(7665):43-51. doi: 10.1038/nature23292.
- Background: PubMed 24679531Belkaid Y, Hand TW. Role of the microbiota in immunity and inflammation. Cell. 2014 Mar 27;157(1):121-41. doi: 10.1016/j.cell.2014.03.011.
- Background: PubMed 29869783Martens K, Pugin B, De Boeck I, Spacova I, Steelant B, Seys SF, Lebeer S, Hellings PW. Probiotics for the airways: Potential to improve epithelial and immune homeostasis. Allergy. 2018 Oct;73(10):1954-1963. doi: 10.1111/all.13495. Epub 2018 Jun 28.
- Background: PubMed 36317983Aggarwal N, Kitano S, Puah GRY, Kittelmann S, Hwang IY, Chang MW. Microbiome and Human Health: Current Understanding, Engineering, and Enabling Technologies. Chem Rev. 2023 Jan 11;123(1):31-72. doi: 10.1021/acs.chemrev.2c00431. Epub 2022 Nov 1.
- Background: PubMed 35300985Psaltis AJ, Mackenzie BW, Cope EK, Ramakrishnan VR. Unraveling the role of the microbiome in chronic rhinosinusitis. J Allergy Clin Immunol. 2022 May;149(5):1513-1521. doi: 10.1016/j.jaci.2022.02.022. Epub 2022 Mar 14.
- Background: PubMed 32167574Paramasivan S, Bassiouni A, Shiffer A, Dillon MR, Cope EK, Cooksley C, Ramezanpour M, Moraitis S, Ali MJ, Bleier B, Callejas C, Cornet ME, Douglas RG, Dutra D, Georgalas C, Harvey RJ, Hwang PH, Luong AU, Schlosser RJ, Tantilipikorn P, Tewfik MA, Vreugde S, Wormald PJ, Caporaso JG, Psaltis AJ. The international sinonasal microbiome study: A multicentre, multinational characterization of sinonasal bacterial ecology. Allergy. 2020 Aug;75(8):2037-2049. doi: 10.1111/all.14276. Epub 2020 Mar 30.
- Individual participant dataSharing planned: No. Data will be presented on group level.
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Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal Polyps
Chronic Rhinosinusitis Without Nasal Polyps
RecruitingObservational study
CRS Questionnaire Validation Project
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
RecruitingPhase 4
Efficacy and Safety of Depemokimab Monotherapy Without Concomitant Use of Intranasal Corticosteroids (INCS) in Japanese Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders Mårtensson, MD, PhD principal investigator
Region Skåne, Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sinonasal microbiome transplant procedure. in people with Chronic Rhinosinusitis Without Nasal Polyps and Chronic Rhinosinusitis With Nasal Polyps, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anders Mårtensson, MD, PhD (0424061000, anders.s.martensson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07184684, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.