Safety of Intranasal Irrigation Probiotics in Healthy Volunteers

NCT02933918 | Completed

• 1 other identifier: PROB001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Keywords

Probiotics; Nasal Irrigation; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Change in sense of smell using the "University of Pennsylvania smell identification test (UPSIT-40)"

  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 from baseline sense of smell at Day 7and Day 14

Secondary Outcomes (4)

• Change in sino-nasal symptomatology using questionnaire

  Change from baseline sino-nasal symptomatology at Day 7, Day 14 and Day 21

• Change in Eustachian tube symptomatology using a questionnaire of Eustachian Tube Dysfunction (ETDQ-7)

  Change from baseline Eustachian tube symptomatology at Day 7, Day 14 and Day 21

• Change in ear examination

  Change from baseline ear examination at Day 7 and Day 14

• Change in anterior rhinoscopy

  Change from baseline anterior rhinoscopy at Day 7 and Day 14

Other Outcomes (1)

• Change in microbiome composition

  Change from baseline microbiome composition at Day 7 and Day 14

Study Arms (1)

Probiotics

EXPERIMENTAL

Other: Probiotics

Interventions

Probiotics OTHER

Safety of nasal irrigation with probiotics in healthy volunteers

Probiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Probionase Therapies Inc.: lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Martin Yvon Desrosiers, MD

  Probionase Therapies Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 14, 2016
• Study Start: May 17, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 18, 2023

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)