NCT04048174

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. 1.Two-week observation period where only saline irrigation is administered.
  2. 2.Treatment period of 14 days (D0 to D14) during which L lactis W136 will be administered twice-daily.
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2015

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
Last Updated

August 12, 2019

Status Verified

July 1, 2019

Enrollment Period

2.7 years

First QC Date

August 6, 2019

Last Update Submit

August 8, 2019

Conditions

Chronic Rhinosinusitis

Keywords

ProbioticsChronic rhinosinusitisIrrigationMicrobiome

Outcome Measures

Primary Outcomes (1)

  • Sino-nasal symptom score

    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.

    6 weeks

Secondary Outcomes (3)

  • SNOT-22

    6 weeks

  • Post Operative Sinus Endoscopy Score (POSE)

    6 weeks

  • Sinus culture (conventional)

    6 weeks

Study Arms (2)

Saline irrigation

SHAM COMPARATOR

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 W136Other: Saline irrigation

Probiotic lactococcus lactis W136 irrigation

EXPERIMENTAL

Each participant performed Probiotic lactococcus lactis W136 nasal irrigation from Day 0 to D14

Other: Topical probiotic treatment with Lactococcus lactis W136Other: Saline irrigation

Interventions

Topical probiotic treatment with Lactococcus lactis W136OTHER

Nasal and sinus irrigation with reconstituted live probiotic bacteria

Also known as: Natural health product
Probiotic lactococcus lactis W136 irrigationSaline irrigation
Saline irrigationOTHER

Nasal and sinus irrigation with saline solution

Also known as: Natural health product
Probiotic lactococcus lactis W136 irrigationSaline irrigation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 1P1, Canada

Location

Related Publications (1)

  • Endam LM, Alromaih S, Gonzalez E, Madrenas J, Cousineau B, Renteria AE, Desrosiers M. Intranasal Application of Lactococcus lactis W136 Is Safe in Chronic Rhinosinusitis Patients With Previous Sinus Surgery. Front Cell Infect Microbiol. 2020 Oct 12;10:440. doi: 10.3389/fcimb.2020.00440. eCollection 2020.

    PMID: 33154953DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 7, 2019

Study Start

March 6, 2013

Primary Completion

December 2, 2015

Study Completion

December 2, 2015

Last Updated

August 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)