Safety of Intranasal Irrigation Probiotics in Healthy Volunteers

Status Completed

Clinical Trial Summary

Chronic rhinosinusitis (CRS) is one of the most common chronic diseases, affecting the quality of life of patients who suffer. Despite medical and surgical treatments available, there are a significant number of people suffering from CRS refractory to these standard treatments. A preliminary clinical trial conducted at CHUM Hôtel-Dieu, has allowed us to evaluate the therapeutic potential of intranasal irrigation of probiotics in patients with CRS. This treatment administered twice daily for 14 days was well tolerated and resulted in improved chronic rhinosinusitis symptoms. Prior to deployment on a larger scale, the safety of this therapy must be confirmed in a healthy population, free of sinus disease. Therefore, this study aims to assess the safety of the use of probiotic intranasal irrigation in healthy volunteers.

Clinical Trial Description

If the participant (healthy volunteer) agrees to participate in the study, and after signing the information consent form, her/his participation in this project will consist to receive the experimental treatment of probiotics, to come to four (4) medical assessment visits at CHUM, over a period of time of four (4) weeks, and answer to one (1) phone call. This study will include five (5) periods : 1. Determination of eligibility period (Day 0) 2. Saline irrigation period (Day 0 to Day 7) 3. Elimination of saline period (Day 8 to Day 14) 4. Probiotic treatment period (Day 15 to Day 21) 5. Telephone follow-up period (Day 22 to Day 28) ;

Study Design

Related Conditions & MeSH terms

Sinusitis

Clinical Trial Details

NCT number	NCT02933918
Study type	Interventional
Source	Probionase Therapies Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 17, 2018
Completion date	December 30, 2019

View Details

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