Intranasal Probiotic rinse for Purulent Chronic Rhinosinusitis

Not Applicable

Recruiting

• Conditions: Chronic Rhinosinusitis; Infection - Other infectious diseases; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12621000004864
• Lead Sponsor: Royal Brisbane and Women's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-07
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[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.]