Nasal Microbiota Transfer Therapy in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Launched by THE UNIVERSITY OF QUEENSLAND · May 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for Chronic Rhinosinusitis without nasal polyps (CRSsNP), a condition that causes long-term inflammation in the nasal passages and can lead to discomfort and other symptoms like nasal blockage and loss of smell. The researchers are exploring a method called Nasal Microbiota Transfer Therapy, where healthy bacteria from a donor’s nose are transplanted to help restore a balanced environment in the nasal passages. Previous small studies have shown that this treatment may significantly improve symptoms for patients, and this trial will compare its effects against a placebo (a treatment that looks the same but has no active ingredients) to see how effective it really is.

To participate, individuals must be between the ages of 18 and 80 and have a diagnosis of Chronic Rhinosinusitis with specific symptoms for at least 12 weeks. They should also have had previous nasal surgery and agree to be part of the study. Participants can expect to undergo procedures related to the treatment, as well as regular follow-ups to monitor their health. It's important to note that there are specific health criteria that could prevent someone from joining the study, such as recent antibiotic use or certain medical conditions, so potential participants will need to discuss their eligibility with the study team. This trial is currently recruiting participants, and involvement could contribute to new insights in managing this challenging condition.

Gender

ALL

Eligibility 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.