None listed
Conditions
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.
Interventions
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
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
Sponsors
Royal Brisbane and Women's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
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
Outcome results
None listed