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Safety of Intranasal Irrigation Probiotics in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02933918
Recruitment Status : Recruiting
First Posted : October 14, 2016
Last Update Posted : September 4, 2018
Information provided by (Responsible Party):
Probionase Therapies Inc.

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.

Condition or disease Intervention/treatment Phase
Sinusitis Other: Probiotics Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Experimental: Probiotics Other: Probiotics
Safety of nasal irrigation with probiotics in healthy volunteers

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. Change in ear examination [ Time Frame: Change from baseline ear examination at Day 7 and Day 14 ]
  4. Change in anterior rhinoscopy [ Time Frame: Change from baseline anterior rhinoscopy at Day 7 and Day 14 ]

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men and women aged 18 and older.
  • Participant in general good health.
  • Absence of nasal and ear signs or symptoms.

Exclusion Criteria:

  • Participant suffering from acute rhinosinusitis, chronic rhinosinusitis, symptomatic allergic rhinitis, or other sinus disease.
  • Participant with diseases of the middle ear causing impairment of the eardrum or middle ear, or have had surgery of the middle ear previously, except myringotomy with insertion tube.
  • Primary or acquired immunodeficiencies documented.
  • Antibiotic intake within 30 days before enrollment.
  • Unable to do nasal rinse.
  • Pregnant woman.
  • Smell score from UPSIT-40 under normal smell threshold (<34).

Information from the National Library of Medicine

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 identifier (NCT number): NCT02933918

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Contact: Leandra Mfuna Endam, Msc 514-890-8000 ext 13278

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Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2X 3E4
Contact: Leandra Mfuna Endam, Msc    514-890-8000 ext 13278   
Principal Investigator: Martin Yvon Desrosiers, MD         
Sponsors and Collaborators
Probionase Therapies Inc.
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Study Chair: Martin Yvon Desrosiers, MD Probionase Therapies Inc.

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Responsible Party: Probionase Therapies Inc. Identifier: NCT02933918    
Other Study ID Numbers: PROB001
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Probionase Therapies Inc.:
Nasal Irrigation
Healthy Volunteers
Additional relevant MeSH terms:
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Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases