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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02933918
Recruitment Status : Unknown
Verified June 2018 by Probionase Therapies Inc..
Recruitment status was:  Recruiting
First Posted : October 14, 2016
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Probionase Therapies Inc.

Tracking Information
First Submitted Date  ICMJE October 6, 2016
First Posted Date  ICMJE October 14, 2016
Last Update Posted Date September 4, 2018
Actual Study Start Date  ICMJE May 17, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 12, 2016)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety of Intranasal Irrigation Probiotics in Healthy Volunteers
Official Title  ICMJE Safety of Intranasal Irrigation Probiotics in Healthy Volunteers
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.

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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sinusitis
Intervention  ICMJE Other: Probiotics
Safety of nasal irrigation with probiotics in healthy volunteers
Study Arms  ICMJE Experimental: Probiotics
Intervention: Other: Probiotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 12, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02933918
Other Study ID Numbers  ICMJE PROB001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Probionase Therapies Inc.
Study Sponsor  ICMJE Probionase Therapies Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Martin Yvon Desrosiers, MD Probionase Therapies Inc.
PRS Account Probionase Therapies Inc.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP