Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-06 @ 8:55 AM
Study NCT ID:
NCT02933918
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2016-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Intranasal Irrigation Probiotics in Healthy Volunteers
Sponsor:
Probionase Therapies Inc.
Organization:
Study Overview
Official Title:
Safety of Intranasal Irrigation Probiotics in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed 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)
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: