An interventional study of Probiotics in Sinusitis, sponsored by Probionase Therapies Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by Probionase Therapies Inc. · Not applicable, Interventional, and Treatment
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.
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 :
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 313 interventional studies indexed under Sinusitis.
Browse Sinusitis studies →This is the only study on the registry with Probionase Therapies Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Probiotics
Safety of nasal irrigation with probiotics in healthy volunteers
Change in sense of smell using the "University of Pennsylvania smell identification test (UPSIT-40)"
A smell test will be conducted using "scratch and sniff fragrance strips" (UPSIT-40), where 40 odors are presented. The participant must choose one of four choices for each odor, even if she/he is unable to identify the smell.
Time frame: Change from baseline sense of smell at Day 7and Day 14
Change in sino-nasal symptomatology using questionnaire
This questionnaire evaluates 5 items (nasal congestion, facial pain, headache, need to blow nose, post-nasal drip) on 0-3 scale (0= none; 1=mild; 2=moderate; 3= severe).
Time frame: Change from baseline sino-nasal symptomatology at Day 7, Day 14 and Day 21
Change in Eustachian tube symptomatology using a questionnaire of Eustachian Tube Dysfunction (ETDQ-7)
Using a questionnaire of Eustachian Tube Dysfunction (ETDQ-7).
Time frame: Change from baseline Eustachian tube symptomatology at Day 7, Day 14 and Day 21
Change in ear examination
Time frame: Change from baseline ear examination at Day 7 and Day 14
Change in anterior rhinoscopy
Time frame: Change from baseline anterior rhinoscopy at Day 7 and Day 14
Change in microbiome composition
Evaluation of the difference in the percentage of the bacterial population before and after treatment.
Time frame: Change from baseline microbiome composition at Day 7 and Day 14
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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