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Safety of Intranasal Irrigation Probiotics in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02933918
Recruitment Status : Not yet recruiting
First Posted : October 14, 2016
Last Update Posted : October 14, 2016
Sponsor:
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 Phase 1

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 three (3) medical assessment visits at CHUM Hôtel-Dieu, over a period of time of three (3) weeks, and answer to one (1) phone call.

This study will include the following four (4) periods :

  1. determination of eligibility period - Day 0
  2. saline irrigation period (for 7 days) - between Day 0 and Day 7
  3. probiotic treatment period ( for 7 days) - between Day 7 and Day 14
  4. telephone follow-up period - Day 21

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Intranasal Irrigation Probiotics in Healthy Volunteers
Study Start Date : November 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Probiotics Other: Probiotics



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

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

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 ClinicalTrials.gov identifier (NCT number): NCT02933918


Contacts
Contact: Leandra Mfuna Endam, Msc 514-890-8000 ext 14170 leandra_mfuna@yahoo.ca

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal, Hôtel-Dieu Not yet recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Leandra Mfuna Endam, Msc    514-890-8000 ext 14170    leandra_mfuna@yahoo.ca   
Principal Investigator: Martin Yvon Desrosiers, MD         
Sponsors and Collaborators
Probionase Therapies Inc.
Investigators
Study Chair: Martin Yvon Desrosiers, MD Probionase Therapies Inc.

Responsible Party: Probionase Therapies Inc.
ClinicalTrials.gov Identifier: NCT02933918     History of Changes
Other Study ID Numbers: PROB001
First Posted: October 14, 2016    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Probionase Therapies Inc.:
Probiotics
Nasal Irrigation
Healthy Volunteers

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases