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Safety of Intranasal Irrigation Probiotics in Healthy Volunteers

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified August 2016 by Probionase Therapies Inc.
Sponsor:
Information provided by (Responsible Party):
Probionase Therapies Inc.
ClinicalTrials.gov Identifier:
NCT02933918
First received: October 6, 2016
Last updated: October 12, 2016
Last verified: August 2016
  Purpose

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 Intervention Phase
Sinusitis Other: Probiotics Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Intranasal Irrigation Probiotics in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Probionase Therapies Inc.:

Primary Outcome Measures:
  • 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:
  • 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 ]

Other Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: November 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotics Other: Probiotics

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
  Eligibility

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

Responsible Party: Probionase Therapies Inc.
ClinicalTrials.gov Identifier: NCT02933918     History of Changes
Other Study ID Numbers: PROB001
Study First Received: October 6, 2016
Last Updated: October 12, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 22, 2017