Status:
UNKNOWN
Nasal Microbiota Transfer Therapy in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Lead Sponsor:
The University of Queensland
Collaborating Sponsors:
Royal Brisbane and Women's Hospital
Monash Health
Conditions:
Chronic Rhinosinusitis (Diagnosis)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Chronic Rhinosinusitis (CRS) is a chronic inflammatory condition of the nasal passage and paranasal sinuses that places significant burden on affected patients and global healthcare systems. Current ...
Detailed Description
Current treatments for CRS such as long-term antibiotics, anti-inflammatory drugs, and surgery often reduce symptoms and signs of disease temporarily, however long-term results are much less satisfact...
Eligibility Criteria
Inclusion
- Inclusion criteria (patient):
- Diagnosis of Chronic Rhinosinusitis as defined by the presence of 2 or more major sinonasal symptoms (nasal blockage, nasal discharge, loss of smell, and facial pain/ fullness) for a minimum of 12 weeks
- Endoscopic confirmation of middle meatus inflammation or presence of mucopurulence, and /or CT confirmation of paranasal sinus inflammation.
- Previous nasal surgery with patent ostia to the diseased ethmoids and maxillary sinuses
- Signed written informed consent
- Inclusion criteria (donor):
- No history of sinonasal or lower airway disease for the last 2 years other than the common cold.
- No clinical findings of sinonasal disease at the inclusion visit.
- Accepted as a donor by the patient.
- Signed informed consent to participate in the study.
- Exclusion Criteria:
- Exclusion criteria (patient):
- Aged \<18 or \>80 years
- Allergy to amoxicillin or clavulanate potassium and Clarithromycin.
- Excessive Nasal polyposis
- Antibiotic treatment in the last 4 weeks
- Patients with a history supporting a diagnosis of immune deficiency will be tested (Immunoglobulin A (IgA), Immunoglobulin M (IgM), Immunoglobulin G (IgG) and IgG subclasses, MBL) and /or are immunocompromised due to disease and / or medication ( e.g., insulin dependent diabetes mellitis, systemic corticosteroids)
- Patients who live with someone who is severly immunocompromised.
- Patients with cystic fibrosis or ciliary dyskinesia
- Patients who have been on an active investigational therapy within 2 months of screening
- Patients who have clinically significant laboratory abnormalities
- Patients who are pregnant, breast feeding or planning to become pregnant during the study
- Patients who are not willing to use a double barrier method of contraception during the study that is:-
- females must use contraceptive pill or Intra-uterine device (IUD) or similar and condoms
- males must use condoms and spermicidal gel
- Patients currently on any medication that may affect the results in an unpredictable manner
- The patient does not agree to comply with or is unable to meet all study requirements for the duration of the study period
- Patients deemed by the investigator to be unsuitable for participation in the study
- Patients who have had Coronavirus-19 (COVID-19) within the last month.
- Exclusion criteria (donor):
- Findings in the prestudy pathogen scan that makes the donor unsuitable. Prestudy pathogen scan: Prior to first donation, the donors will be tested for HIV, Human T-lymphotropic virus 1 and 2, Hepatitis B and C, Syphilis, Tuberculosis, Herpes Simplex (HSV 1 and 2), Varicella Zoster (VZV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Methicillin-resistant Staphylococcus aureus (MRSA) and a standard panel for sinonasal pathogens (Pneumococci, H. Influenza, Beta-streptococci and M. Catarrhalis).
- Donors who have had COVID-19 within the last 2 months.
- If the donor is positive for Herpes Simplex, CMV or EBV they will be considered unsuitable as a donor for a patient negative for the same pathogen. If the donor is positive for any other pathogen they will be considered unsuitable as a donor entirely.
Exclusion
Key Trial Info
Start Date :
November 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05400616
Start Date
November 10 2022
End Date
December 1 2025
Last Update
December 7 2023
Active Locations (3)
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1
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4006
2
University of Queensland
Brisbane, Queensland, Australia, 4680
3
Monash Health
Melbourne, Australia