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New treatment option for Chronic Rhinosinusitis Without Nasal Polyps
Official title Sinonasal Microbiome Transplant as a Therapy for Chronic Rhinosinusitis (CRS).
ClinicalTrials.gov ID: NCT07184684
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- (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.
You likely can't join if
- (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.
See the full eligibility 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.
- (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.
The study team makes the final eligibility decision.
Where it's taking place
- Helsingborg, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Helsingborg, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.