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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)
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Scientific title
Phase-II Randomized Control Trial of Nasal Microbiota Transplant Therapy in Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
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Secondary ID [1]
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University of Queensland
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis (Diagnosis)
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Sino-Nasal Outcome Test (SNOT-22) - 22 Item Questionnaire
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Assessment method [1]
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Change of burden of disease as measured by the SNOT-22 (22 item sinonasal outcome test) questionnaire in patients. Each item graded 0-5.
Minimum score 0, Maximum 105 Interpretation: Higher score indicates poorer disease control.
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Timepoint [1]
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Week 1 (Day 1) to Week 20
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Secondary outcome [1]
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Lund-Kennedy endoscopic assessment score
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Assessment method [1]
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Change of grading of disease severity using the Lund-Kennedy endoscopy score based on clinical assessment of the middle meatus. 4-item criteria, with score of 0-2 Minimum score: 0, Maximum 8 Interpretation: Higher score indicates a higher degree of disease severity based on clinical assessment.
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Timepoint [1]
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Week 1 (Day 1) to Week 20
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Secondary outcome [2]
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Characterisation of nasal microbiome in study participants
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Assessment method [2]
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Change in nasal microbiome associated with clinical outcomes such as decrease in presence, absence or abundance of bacterial pathogens.
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Timepoint [2]
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Week 1 (Day 1) to Week 20
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Secondary outcome [3]
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Characterisation of microbiome within effective donors as compared to ineffective donors
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Assessment method [3]
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Analysis of microbes (bacterial strains, viruses and fungi), and human cell types within donor specimens.
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Timepoint [3]
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Week 1 (Day 1) - Week 2 (Day 9)
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Secondary outcome [4]
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Adverse events of Participating Patients
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Assessment method [4]
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Any adverse event
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Timepoint [4]
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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).
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Secondary outcome [5]
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Cytokine level - Interleukin 5 or (IL-5)
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Assessment method [5]
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Change of lL-5 in nasal secretion/swab markers across duration of study. Each cytokine will be quantified using a highly sensitive immunoassay which will use biotinylated antibodies specific to each cytokine to bind the cytokine molecules in the sample. Interactions measured on a flow cytometer and compared against its relevant standard. this will result in a measure of the total concentration of the cytokine in the sample (pg/ml).
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Timepoint [5]
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Week 1 (Day 1) to Week 20
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Secondary outcome [6]
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Cytokine level - Interleukin 13 (IL-13)
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Assessment method [6]
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Change of lL-13 in nasal secretion/swab markers across duration of study. Each cytokine will be quantified using a highly sensitive immunoassay which will use biotinylated antibodies specific to each cytokine to bind the cytokine molecules in the sample.
Interactions measured on a flow cytometer and compared against its relevant standard. this will result in a measure of the total concentration of the cytokine in the sample (pg/ml).
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Timepoint [6]
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Week 1 (Day 1) to Week 20
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Secondary outcome [7]
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Cytokine level - Interleukin 2 (IL-2)
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Assessment method [7]
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Change of lL-2 in nasal secretion/swab markers across duration of study. Each cytokine will be quantified using a highly sensitive immunoassay which will use biotinylated antibodies specific to each cytokine to bind the cytokine molecules in the sample.
Interactions measured on a flow cytometer and compared against its relevant standard. this will result in a measure of the total concentration of the cytokine in the sample (pg/ml).
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Timepoint [7]
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Week 1 (Day 1) to Week 20
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Secondary outcome [8]
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Cytokine level - Interleukin 6 (IL-6)
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Assessment method [8]
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Change of lL-6 in nasal secretion/swab markers across duration of study.Each cytokine will be quantified using a highly sensitive immunoassay which will use biotinylated antibodies specific to each cytokine to bind the cytokine molecules in the sample.
Interactions measured on a flow cytometer and compared against its relevant standard. this will result in a measure of the total concentration of the cytokine in the sample (pg/ml).
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Timepoint [8]
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Week 1 (Day 1) to Week 20
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Secondary outcome [9]
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Cytokine level - Interleukin 10 (IL-10)
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Assessment method [9]
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Change of lL-10 in nasal secretion/swab markers across duration of study.Each cytokine will be quantified using a highly sensitive immunoassay which will use biotinylated antibodies specific to each cytokine to bind the cytokine molecules in the sample.
Interactions measured on a flow cytometer and compared against its relevant standard. this will result in a measure of the total concentration of the cytokine in the sample (pg/ml).
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Timepoint [9]
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Week 1 (Day 1) to Week 20
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Secondary outcome [10]
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Cytokine level - Interferon gamma (IFN-?)
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Assessment method [10]
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Change of IFN-Y in nasal secretion/swab markers across duration of study.Each cytokine will be quantified using a highly sensitive immunoassay which will use biotinylated antibodies specific to each cytokine to bind the cytokine molecules in the sample.
Interactions measured on a flow cytometer and compared against its relevant standard. this will result in a measure of the total concentration of the cytokine in the sample (pg/ml).
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Timepoint [10]
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Week 1 (Day 1) to Week 20
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Secondary outcome [11]
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Cytokine level - Interleukin 4 (IL-4)
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Assessment method [11]
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Change of IL-4 in nasal secretion/swab markers across duration of study.Each cytokine will be quantified using a highly sensitive immunoassay which will use biotinylated antibodies specific to each cytokine to bind the cytokine molecules in the sample.
Interactions measured on a flow cytometer and compared against its relevant standard. this will result in a measure of the total concentration of the cytokine in the sample (pg/ml).
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Timepoint [11]
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Week 1 (Day 1) to Week 20
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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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/11/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [2]
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University of Queensland - Brisbane
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Recruitment hospital [3]
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Monash Health - Melbourne
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Recruitment postcode(s) [1]
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4006 - Brisbane
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Recruitment postcode(s) [2]
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4680 - Brisbane
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Recruitment postcode(s) [3]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Government body
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Name [1]
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Royal Brisbane and Women's Hospital
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Monash Health
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Queensland University of Technology
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
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 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 satisfactory. Recently, the theory of a damaged microbiome (dysbiosis) as a cause or promoting factor behind CRS has gained increasing evidence from the scientific community. A condition of the gut with microbial dysbiosis (c.difficile) has previously employed microbiota transplant treatment with great success in long-term health outcomes. Such treatments are shown to repopulate bacterial microenvironment and restore protective commensal bacterial load. A pilot study conducted by this study team trialed a novel intervention of a Nasal Microbiota Transplant in a small group of participants. Preliminary results suggested significantly improved CRS symptoms after treatment with a healthy donor microbiota transplant, compared to the pre-transplant baseline. The addition of a randomized-control trial with inclusion of a placebo group is the next step. In this study, investigators aim to perform a two-arm, double-blinded, phase II randomized controlled clinical trial in order to assess the efficacy of a Nasal Microbiota Transplant against a placebo in a cohort of CRS patients without Nasal Polyps (CRSsNP).
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Trial website
https://clinicaltrials.gov/study/NCT05400616
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Trial related presentations / publications
Marsh RL, Aho C, Beissbarth J, Bialasiewicz S, Binks M, Cervin A, Kirkham LS, Lemon KP, Slack MPE, Smith-Vaughan HC. Panel 4: Recent advances in understanding the natural history of the otitis media microbiome and its response to environmental pressures. Int J Pediatr Otorhinolaryngol. 2020 Mar;130 Suppl 1(Suppl 1):109836. doi: 10.1016/j.ijporl.2019.109836. Epub 2019 Dec 18. Cho DY, Hunter RC, Ramakrishnan VR. The Microbiome and Chronic Rhinosinusitis. Immunol Allergy Clin North Am. 2020 May;40(2):251-263. doi: 10.1016/j.iac.2019.12.009. Epub 2020 Jan 16. Psaltis AJ, Wormald PJ. Therapy of Sinonasal Microbiome in CRS: A Critical Approach. Curr Allergy Asthma Rep. 2017 Sep;17(9):59. doi: 10.1007/s11882-017-0726-x. Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000. Mahdavinia M, Keshavarzian A, Tobin MC, Landay AL, Schleimer RP. A comprehensive review of the nasal microbiome in chronic rhinosinusitis (CRS). Clin Exp Allergy. 2016 Jan;46(1):21-41. doi: 10.1111/cea.12666. Buckland JR, Thomas S, Harries PG. Can the Sino-nasal Outcome Test (SNOT-22) be used as a reliable outcome measure for successful septal surgery? Clin Otolaryngol Allied Sci. 2003 Feb;28(1):43-7. doi: 10.1046/j.1365-2273.2003.00663.x. Rudmik L. Economics of Chronic Rhinosinusitis. Curr Allergy Asthma Rep. 2017 Apr;17(4):20. doi: 10.1007/s11882-017-0690-5. Wagner Mackenzie B, Waite DW, Hoggard M, Douglas RG, Taylor MW, Biswas K. Bacterial community collapse: a meta-analysis of the sinonasal microbiota in chronic rhinosinusitis. Environ Microbiol. 2017 Jan;19(1):381-392. doi: 10.1111/1462-2920.13632. Epub 2017 Jan 18.
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Public notes
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Contacts
Principal investigator
Name
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Anders Cervin, MD,FRACS
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Address
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University of Queensland/Royal Brisbane and Women's Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Anders Cervin, MD,FRACS
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Address
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Phone
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617 3497 3588
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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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