SinusitisNCT02933918
Safety of Intranasal Irrigation Probiotics in Healthy Volunteers
A study testing Probiotics in people with Sinusitis, run by Probionase Therapies Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinusitis
- What is being tested?
- Probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 17 May 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 and older.
- Participant in general good health.
- Absence of nasal and ear signs or symptoms.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
About this study
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.
Read the 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 :
- 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)
- Conditions
- Sinusitis
- Being tested
- Probiotics
- Keywords
- Probiotics, Nasal Irrigation, Healthy Volunteers
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsOther
Safety of nasal irrigation with probiotics in healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Not described Receives: Other: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline sense of smell at Day 7and Day 14
Secondary outcomes (4)
Change in sino-nasal symptomatology using questionnaire
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).
Measured: 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)
Using a questionnaire of Eustachian Tube Dysfunction (ETDQ-7).
Measured: Change from baseline Eustachian tube symptomatology at Day 7, Day 14 and Day 21
Change in ear examination
Measured: Change from baseline ear examination at Day 7 and Day 14
Change in anterior rhinoscopy
Measured: Change from baseline anterior rhinoscopy at Day 7 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start17 May 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probionase Therapies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Yvon Desrosiers, MD, Study chair, Probionase Therapies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933918
- Sponsor's protocol ID
- PROB001
- Status last verified
- Aug 2019
- First submitted
- 6 Oct 2016
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Intranasal Irrigation Probiotics in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02933918
- Acronym / sponsor ID
- PROB001
- Conditions
- Sinusitis
- Keywords
- Probiotics, Nasal Irrigation, Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Probionase Therapies Inc.Industry (pharma, biotech, devices)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Other: Probiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged 18 and older.
- Participant in general good health.
- Absence of nasal and ear signs or symptoms.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsSafety of nasal irrigation with probiotics in healthy volunteers | Other | Probiotics |
Primary outcome
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.
4 secondary outcomes
Change in sino-nasal symptomatology using questionnaire
Time frame: 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)
Time frame: Change from baseline Eustachian tube symptomatology at Day 7, Day 14 and Day 21
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Yvon Desrosiers, MD study chair
Probionase Therapies Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Sinusitis, run by Probionase Therapies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.