Effect of an Intranasal Probiotic rinse on the nasal microbiome of adults with Purulent Chronic Rhinosinusitis

Royal Brisbane and Women's Hospital0 个研究点目标入组 40 人开始时间: 2021年1月7日最近更新: 2021年4月26日

适应症

试验速览

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•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

•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

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