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NCT Number: NCT02933918

Safety of Intranasal Irrigation Probiotics in Healthy Volunteers

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

About this study

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 :

  • Determination of eligibility period (Day 0)
  • Saline irrigation period (Day 0 to Day 7)
  • Elimination of saline period (Day 8 to Day 14)
  • Probiotic treatment period (Day 15 to Day 21)
  • Telephone follow-up period (Day 22 to Day 28)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Probiotics

Other

Safety of nasal irrigation with probiotics in healthy volunteers

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Probionase Therapies Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 14, 2016
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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