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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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics | Other | Safety of nasal irrigation with probiotics in healthy volunteers |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline sense of smell at Day 7and Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiome composition | Evaluation of the difference in the percentage of the bacterial population before and after treatment. | Change from baseline microbiome composition at Day 7 and Day 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Yvon Desrosiers, MD | Probionase Therapies Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 3E4 | Canada |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Using a questionnaire of Eustachian Tube Dysfunction (ETDQ-7). |
| Change from baseline Eustachian tube symptomatology at Day 7, Day 14 and Day 21 |
| Change in ear examination | Change from baseline ear examination at Day 7 and Day 14 |
| Change in anterior rhinoscopy | Change from baseline anterior rhinoscopy at Day 7 and Day 14 |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D019602 |
| Food and Beverages |