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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05400616




Registration number
NCT05400616
Ethics application status
Date submitted
12/05/2022
Date registered
1/06/2022

Titles & IDs
Public title
Nasal Microbiota Transfer Therapy in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Scientific title
Phase-II Randomized Control Trial of Nasal Microbiota Transplant Therapy in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Secondary ID [1] 0 0
University of Queensland
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis (Diagnosis) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Microbiome Transplant
Treatment: Surgery - Placebo

Experimental: Intervention - For each nostril, the donated nasal wash sample is quiesced to 15 mls with saline Nasal Microbiota Transplant therapy.

Placebo comparator: Control - For each nostril, 15 mls of saline will be used as the placebo therapy.


Treatment: Surgery: Microbiome Transplant
A raw microbiome, is collected from a donor without any sinonasal health problems, as a nasal lavage.

Treatment: Surgery: Placebo
Normal saline.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sino-Nasal Outcome Test (SNOT-22) - 22 Item Questionnaire
Timepoint [1] 0 0
Week 1 (Day 1) to Week 20
Secondary outcome [1] 0 0
Lund-Kennedy endoscopic assessment score
Timepoint [1] 0 0
Week 1 (Day 1) to Week 20
Secondary outcome [2] 0 0
Characterisation of nasal microbiome in study participants
Timepoint [2] 0 0
Week 1 (Day 1) to Week 20
Secondary outcome [3] 0 0
Characterisation of microbiome within effective donors as compared to ineffective donors
Timepoint [3] 0 0
Week 1 (Day 1) - Week 2 (Day 9)
Secondary outcome [4] 0 0
Adverse events of Participating Patients
Timepoint [4] 0 0
From the day participating patients give signed consent (2-4 weeks before baseline) until the day of their End of study visit (Up to 33 weeks).
Secondary outcome [5] 0 0
Cytokine level - Interleukin 5 or (IL-5)
Timepoint [5] 0 0
Week 1 (Day 1) to Week 20
Secondary outcome [6] 0 0
Cytokine level - Interleukin 13 (IL-13)
Timepoint [6] 0 0
Week 1 (Day 1) to Week 20
Secondary outcome [7] 0 0
Cytokine level - Interleukin 2 (IL-2)
Timepoint [7] 0 0
Week 1 (Day 1) to Week 20
Secondary outcome [8] 0 0
Cytokine level - Interleukin 6 (IL-6)
Timepoint [8] 0 0
Week 1 (Day 1) to Week 20
Secondary outcome [9] 0 0
Cytokine level - Interleukin 10 (IL-10)
Timepoint [9] 0 0
Week 1 (Day 1) to Week 20
Secondary outcome [10] 0 0
Cytokine level - Interferon gamma (IFN-?)
Timepoint [10] 0 0
Week 1 (Day 1) to Week 20
Secondary outcome [11] 0 0
Cytokine level - Interleukin 4 (IL-4)
Timepoint [11] 0 0
Week 1 (Day 1) to Week 20

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
University of Queensland - Brisbane
Recruitment hospital [3] 0 0
Monash Health - Melbourne
Recruitment postcode(s) [1] 0 0
4006 - Brisbane
Recruitment postcode(s) [2] 0 0
4680 - Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Royal Brisbane and Women's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Monash Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Queensland University of Technology
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anders Cervin, MD,FRACS
Address 0 0
University of Queensland/Royal Brisbane and Women's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anders Cervin, MD,FRACS
Address 0 0
Country 0 0
Phone 0 0
617 3497 3588
Fax 0 0
Email 0 0
a.cervin@uq.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There may be a possibility to share deidentified individual outcome data upon request, if the request is in accordance with the privacy statements of this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05400616