Nasal microbiota transfer therapy for chronic rhinosinusitis without nasal polyps
Phase-II Randomized Control Trial of Nasal Microbiota Transplant Therapy in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
This study is testing if transferring healthy bacteria into the noses of people with chronic rhinosinusitis without nasal polyps can help them feel better and improve their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The University of Queensland Academic / other |
| Locations | 3 sites (Brisbane, Queensland and 2 other locations) |
| Trial ID | NCT05400616 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of nasal microbiota transfer therapy as a treatment for chronic rhinosinusitis without nasal polyps (CRSsNP). The approach involves transplanting healthy nasal microbiota to patients suffering from CRSsNP to potentially restore a balanced microbiome and improve long-term health outcomes. Participants will undergo microbiome transplants over a two-week period, with follow-up assessments for up to six months. The study aims to enhance understanding of the nasal microbiome's role in respiratory health and its implications for related conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with a diagnosis of chronic rhinosinusitis without nasal polyps and specific symptoms persisting for at least 12 weeks.
Not a fit: Patients with excessive nasal polyposis, those under 18 or over 80 years old, or individuals with certain allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a long-term solution for patients with chronic rhinosinusitis, reducing reliance on antibiotics and improving overall respiratory health.
How similar studies have performed: While microbiota transplant has shown success in treating other conditions, this specific approach for chronic rhinosinusitis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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:- 1. females must use contraceptive pill or Intra-uterine device (IUD) or similar and condoms 2. 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.
Where this trial is running
Brisbane, Queensland and 2 other locations
- Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia (Recruiting)
- University of Queensland — Brisbane, Queensland, Australia (Not_yet_recruiting)
- Monash Health — Melbourne, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Anders Cervin, MD,FRACS
- Email: a.cervin@uq.edu.au
- Phone: 617 3497 3588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.