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Trial registered on ANZCTR


Registration number
ACTRN12621000004864
Ethics application status
Approved
Date submitted
28/10/2020
Date registered
7/01/2021
Date last updated
7/01/2021
Date data sharing statement initially provided
7/01/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intranasal Probiotic rinse for Purulent Chronic Rhinosinusitis
Scientific title
Effect of an Intranasal Probiotic rinse on the nasal microbiome of adults with Purulent Chronic Rhinosinusitis
Secondary ID [1] 302645 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
iPro20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis 319550 0
Condition category
Condition code
Infection 317499 317499 0 0
Other infectious diseases
Respiratory 317808 317808 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study duration is a maximum of 16 weeks +/- 3days. The subjects are screened at the ENT clinic then will attend a baseline visit 2-4 weeks after screening. The first dose of the intervention will be administered at the baseline visit. Nasal Probiotic rinse will then be administered by the subject once daily for a 4 week period. The patient will then attend an end of treatment visit which is followed by an 8 week follow up period and then an end of study assessment visit.
The intervention will occur at Baseline visit after all inclusion exclusion details are confirmed and all other baseline procedures have been performed. The subject will first watch a video made by the principal investigator to demonstrate the specific method for the administration of the probiotic powder via nasal rinse. The first intervention will then be performed by the subject in the presence of the research nurse to ensure competency. Subsequent daily treatments will be performed by subject at home . The subject will also be given a step by step administration guide to remind them of the correct procedure. The intervention powder jar has a serial number which will be recorded in a dispensation and accountability log. The patient will return the jar with any remaining powder at end of treatment and remaining powder will be weighed to calculate compliance. An administration log is also given to patient for them to record time and date of each dose administered to aid compliance. At the phone interviews ( I week and 2 weeks after baseline) the subject will also be asked if there has been any difficultly administering doses and if any doses have been missed.
To administer the Probiotic powder one scoop of the powder is added to 200mls of lukewarm normal saline and administered using a Flo sinus wash bottle to nasal sinuses.
Probiotic powder consists of the following probiotic strains and quantity per dose :-
Lactobacillus Rhamnosus SP- one billion colony forming bacteria
Lactobacillus Paracasei 101/37- one billion colony forming bacteria
Lactobacillus Rhamnosus CRL 1505- one billion colony forming bacteria
Lactobacillus Planetarium 931- one billion colony forming bacteria
Intervention code [1] 318938 0
Treatment: Other
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325533 0
Any changes in the nasal microbiome associated with health such as a decrease in the presense or abundance of bacterial pathogens and/or increase or new presense of bacterial commensals. This will be assessed by the collection of nasal swabs at each visit . The subjects will also have a videoed nasal endoscopy at each visit which is scored using the Lund Kennedy score to note any visible changes that may occur in the sinuses.
Timepoint [1] 325533 0
The patients will attend visits for assessment at the ENT clinic at the end of their 4 weeks of treatment and 8 weeks after the end of treatment.
Secondary outcome [1] 388321 0
Change in lund kennedy endoscopic assessment score of middle meatus
Timepoint [1] 388321 0
After 4 weeks of treatment and 8 weeks after completion of treatment
Secondary outcome [2] 388322 0
.
Any change in rhinosinusitis symptoms will be measured using SNOT-22 questionnaires . The total scores will be used to assess if there has been any increase or decrease in symptoms.
Timepoint [2] 388322 0
After 4 weeks of treatment and 8 weeks after end of treatment.
Secondary outcome [3] 388323 0

Any changes in quality of life will be assessed by using SF36 questionnaire scores.
Timepoint [3] 388323 0
After 4 weeks of treatment and 8 weeks after end of treatment
Secondary outcome [4] 388324 0

Any change in nasal secretion level of cytokines. This is an exploratory outcome that will be measured using a nasal sponge specifically designed to collect nasal secretions. .
Timepoint [4] 388324 0
After 4 weeks of Treatment and 8 weeks after end of treatment
Secondary outcome [5] 388325 0

Any colonisation with 1 or more of the bacterial strains contained in the probiotic rinse will be assessed using microbiology analysis of nasal swabs collected.
Timepoint [5] 388325 0
After 4 weeks of treatment and 8 weeks after end of treatment
Secondary outcome [6] 389279 0
Safety of administration of probiotic powder via nasal sinuses.
This will be measured by recording any adverse events and rating them by the principal investigator as to if they have any likely attribution/ relatedness to the intervention process or product. Also haematology and biochemistry tests will be reviewed to ensure that any changes from baseline are reviewed and if present assessed by the PI to see if there is any possible attribution /relatedness to the intervention product.
Timepoint [6] 389279 0
4 weeks after commencement of treatment and 8 weeks after end of treatment

Eligibility
Key inclusion criteria
1.Diagnosis of CS as defined by:-
a. 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 and,
b. Endoscopic confirmation of middle meatus inflammation or presence of mucoprulence, and /or CT confirmation of paranasal sinus inflammation.
2. Previous nasal surgery with patent ostia to the diseased ethmoids and maxillary sinuses
3. Signed written informed consent
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Patients aged <18 or >70 years
2 Intolerance to nasal topical anesthesia, starch or maltodextrin (carriers in the probiotic powder)
3 Chronic Rhinosinusitis with nasal polyps
4. Previous adverse reaction to doxycycline
5. Patients with immune deficiency and /or are immunocompromised due to disease and / or medication
6. Patients who live with someone who is severely immunocompromised.
7. Patients with cystic fibrosis or ciliary dyskinesia
8. Patients who have been on an active investigational therapy within 2 months of screening
9. Patients who have clinically significant laboratory abnormalities
10. Patients who are pregnant, breast feeding or planning to become pregnant during the study
11. Patients who are not willing to use a double barrier method of contraception during the study that is:-
a) females must use contraceptive pill or IUD or similar and condoms
b) males must use condoms and spermicidal gel
12. Patients currently on any medication that may affect the results in an unpredictable manner
13. The patient does not agree to comply with or is unable to meet all study requirements for the duration of the study period
14. Patients deemed by the investigator to be unsuitable for participation in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
BASELINE DESCRIPTIVE STATISTICS
Subject demographics, clinical information, and procedural characteristics will be summarized. Continuous variables will be presented as mean, standard deviation, and 95% confidence intervals for the mean. Discrete variables will be presented as frequencies, percentages and exact 95% confidence intervals for discrete variables.
ADDITIONAL SUB-GROUP ANALYSES
Using the above methods, colonised vs non-colonised sub-groups will be analysed for efficacy and reduction in abundance of pathogens.
SAMPLE SIZE-
Up to 40 participants.This is a proof of concept study in which we are attempting to colonise the upper respiratory of the participants with the probiotic bacterial strains and we are assessing if the treatment leads to any product related adverse events.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/11/2020
Date of last participant enrolment
Anticipated
27/08/2021
Actual
Date of last data collection
Anticipated
4/11/2021
Actual
Sample size
Target
40
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 17909 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 31770 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 307080 0
Hospital
Name [1] 307080 0
Royal Brisbane and Women's Hospital
Country [1] 307080 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield Street
Herston
QLD 4029
Country
Australia
Secondary sponsor category [1] 307649 0
None
Name [1] 307649 0
Address [1] 307649 0
Country [1] 307649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307198 0
Royal Brisbane and Women's hospital, Metro North
Ethics committee address [1] 307198 0
Executive Suites, Lower Ground Floor, Dr James Mayne Building,40 Butterfield Street,Royal Brisbane & Women's Hospital, QLD, Herston,4029
Ethics committee country [1] 307198 0
Australia
Date submitted for ethics approval [1] 307198 0
08/10/2020
Approval date [1] 307198 0
22/10/2020
Ethics approval number [1] 307198 0
HREC/2018/QRBW/44302

Summary
Brief summary
This is a Phase 1 ,Single arm open label clinical trial. The objective of this clinical trial is to test an alternative treatment to antibiotics in a small group of
Chronic Rhinosinusitis (CRS) patients to evaluate safety, efficacy of a 4 strain lactobacilli probiotic nasal rinse. The study population will consist of up to 40 patients with a
diagnosis of CRS. Patients will be invited to participate in a 14-16-week program from screening to End of Study. At the screening visit the patient will be reviewed and perform assessments to ensure the suitability of the patient to partake in the trial. The suitability will be checked using inclusion /exclusion criteria. Before any assessments take place the patient will asked to sign a patient information and consent form. This form will have been sent to patient to review prior to screening day. The subject if suitable for enrolment will attend a baseline visit 2-4 weeks after screening. At the Baseline visit the patient will have inclusion/exclusion criteria rechecked before being enrolled and commenced on the intervention ( Probiotic powder administered via nasal rinse) . Each patient will be trained under supervision in the clinic on how to self-administer the probiotic nasal rinse. The patient will then administer the probiotic rinse once daily at home for 4 weeks when they will attend an end of treatment visit at the ENT clinic. The patients will then be followed up for a further 8 weeks then will attend an End of study visit. The overall aim of this study is to improve quality of life by reducing the pathogen load and increasing beneficial bacteria in the nasal microbiome of Chronic Rhinosinusitis sufferers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106374 0
Prof Anders Cervin
Address 106374 0
ENT department,
Level 8 Ned Hanlon building,
Royal Brisbane and Women's Hospital,
40 Butterfield street,
Herston,
Queensland, 4029
Country 106374 0
Australia
Phone 106374 0
+61 7 3647 0182
Fax 106374 0
Email 106374 0
[email protected]
Contact person for public queries
Name 106375 0
Kathryn Girling
Address 106375 0
Level 8 Ned Hanlon building,
Royal Brisbane and Women's Hospital,
40 Butterfield street,
Herston,
Queensland, 4029
Country 106375 0
Australia
Phone 106375 0
+61 7 3646 0946
Fax 106375 0
Email 106375 0
[email protected]
Contact person for scientific queries
Name 106376 0
Anders Cervin
Address 106376 0
Level 8 Ned Hanlon building,
Royal Brisbane and Women's Hospital,
40 Butterfield street,
Herston,
Queensland, 4029
Country 106376 0
Australia
Phone 106376 0
+61 7 3647 0182
Fax 106376 0
Email 106376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9559Informed consent form    380829-(Uploaded-28-10-2020-12-42-07)-Study-related document.pdf



Results publications and other study-related documents

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