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Safety and Efficacy of Lactococcus Lactis Probiotic Bacteria for the Treatment of Chronic Rhinosinusitis

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: NCT04048174
Recruitment Status : Completed
First Posted : August 7, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

Despite advances in medical treatments and surgery for chronic rhinosinusitis (CRS), there remains a large number of patients who continue to suffer from chronic sinusitis despite standard therapies. This research project has the goal of evaluating the safety and effectiveness of a potentially novel therapy for patients with CRS refractory to medical and surgical therapies, consisting of the introduction of a live probiotic bacteria (L lactis W136) directly into the nasal and sinus cavities via irrigation.

In total, 24 patients suffering from refractory CRS will be recruited from ongoing clinical activities by the research team of Martin Desrosiers at the CHUM hospital. Study duration is six weeks, and will be performed in three phases, with six visits planned in total.

  1. Two-week observation period where only saline irrigation is administered.
  2. Treatment period of 14 days (D0 to D14) during which L lactis W136 will be administered twice-daily.
  3. Post treatment observation period of two weeks (D14 to D28) during which the patient will cease probiotic but will continue to irrigate his nose with only saline.

Assessment will use symptom questionnaires, quality of life questionnaires and endoscopic examination of the sinus cavities. Sinus culture will be performed at each visit to assess development of unusual infections. Exploratory assessments of gene expression and microbiome profiling will be performed to explore underlying mechanisms.


Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Other: Topical probiotic treatment with Lactococcus lactis W136 Other: Saline irrigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Lactococcus Lactis Probiotic Bacteria for the Treatment of Chronic Rhinosinusitis
Actual Study Start Date : March 6, 2013
Actual Primary Completion Date : December 2, 2015
Actual Study Completion Date : December 2, 2015

Arm Intervention/treatment
Sham Comparator: Saline irrigation

Each participant performed nasal saline irrigation at 2 periods:

  • Day -14 to Day 0
  • Day 14 to Day 28
Other: Topical probiotic treatment with Lactococcus lactis W136
Nasal and sinus irrigation with reconstituted live probiotic bacteria
Other Name: Natural health product

Other: Saline irrigation
Nasal and sinus irrigation with saline solution
Other Name: Natural health product

Experimental: Probiotic lactococcus lactis W136 irrigation
Each participant performed Probiotic lactococcus lactis W136 nasal irrigation from Day 0 to D14
Other: Topical probiotic treatment with Lactococcus lactis W136
Nasal and sinus irrigation with reconstituted live probiotic bacteria
Other Name: Natural health product

Other: Saline irrigation
Nasal and sinus irrigation with saline solution
Other Name: Natural health product




Primary Outcome Measures :
  1. Sino-nasal symptom score [ Time Frame: 6 weeks ]

    Subjective symptoms of nasal function.

    The sino-nasal symtom score (SNSS) is the sum of the following nasal and sinus symptoms:

    1. Nasal obstruction
    2. Facial pain
    3. Need to blow nose
    4. Headache
    5. Post-nasal drip

    Each individual item is scored on a 0-3 ordinal scale, with a higher score indicating a worst/more severe symptom. The TNSS is the sum of the five symptoms and has a range of 0-15. A lower score is better.



Secondary Outcome Measures :
  1. SNOT-22 [ Time Frame: 6 weeks ]
    SNOT-22 validated disease - specific quality of life score. The Sino-Nasal Outcome Test is a validated, disease specific quality of life questionnaire. It contains 22 items, which contributes to the SNOT-22 acronym. Each of the individual items is scored on a 0-5 ordinal score. A higher score indicate worst quality of life. Individual results are summed with equal weight. The sum is the SNOT-22 score, which has a range of 0-110. A lower score is better.

  2. Post Operative Sinus Endoscopy Score (POSE) [ Time Frame: 6 weeks ]

    Validated endoscopic scoring system. The Perioperative Sinus Endoscopy score assesses the condition of the sinuses and sinus mucosa as assessed with direct endoscopic visualization of the sinus passages. Presence of oedema, polyps, scarring and nasal secretions, and status of the principal sinus drainage passages (frontal and sphenoid), are assessed on a 0-2 ordinal scale. A higher score indicate worse disease.

    POSE score is determined as the sum of each of the individual items and has a range of 0-12.


  3. Sinus culture (conventional) [ Time Frame: 6 weeks ]
    Swab culture for monitoring of infection/probiotic over growth



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • refractory chronic rhinosinusitis (CRS)
  • persistence of symptoms of CRS despite previous endoscopic sinus surgery (ESS) and ongoing medical management

Exclusion Criteria:

  • patients <18 years
  • cystic fibrosis
  • technical reasons for ESS failure
  • active sinus infection with purulence pain and/or hyperthermia
  • immune suppression from disease or medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04048174


Locations
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Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 1P1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
McGill University

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT04048174    
Other Study ID Numbers: CE12.288
191920 ( Other Identifier: Health Canada )
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Probiotics
Chronic rhinosinusitis
Irrigation
Microbiome
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases