Safety of Intranasal Irrigation Probiotics in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT02933918|
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : September 4, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis||Other: Probiotics||Not Applicable|
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 :
- Determination of eligibility period (Day 0)
- Saline irrigation period (Day 0 to Day 7)
- Elimination of saline period (Day 8 to Day 14)
- Probiotic treatment period (Day 15 to Day 21)
- Telephone follow-up period (Day 22 to Day 28)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Intranasal Irrigation Probiotics in Healthy Volunteers|
|Actual Study Start Date :||May 17, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
Safety of nasal irrigation with probiotics in healthy volunteers
- Change in sense of smell using the "University of Pennsylvania smell identification test (UPSIT-40)" [ Time Frame: Change from baseline sense of smell at Day 7and Day 14 ]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 in sino-nasal symptomatology using questionnaire [ Time Frame: Change from baseline sino-nasal symptomatology at Day 7, Day 14 and Day 21 ]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 in Eustachian tube symptomatology 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 ]Using a questionnaire of Eustachian Tube Dysfunction (ETDQ-7).
- 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 [ Time Frame: Change from baseline microbiome composition at Day 7 and Day 14 ]Evaluation of the difference in the percentage of the bacterial population before and after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02933918
|Contact: Leandra Mfuna Endam, Msc||514-890-8000 ext firstname.lastname@example.org|
|Centre Hospitalier de l'Université de Montréal||Recruiting|
|Montreal, Quebec, Canada, H2X 3E4|
|Contact: Leandra Mfuna Endam, Msc 514-890-8000 ext 13278 email@example.com|
|Principal Investigator: Martin Yvon Desrosiers, MD|
|Study Chair:||Martin Yvon Desrosiers, MD||Probionase Therapies Inc.|