NCT04048174

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

Completed NA Last updated 12 August 2019

What this trial tests

NA trial testing Topical probiotic treatment with Lactococcus lactis W136 in Chronic Rhinosinusitis in 27 participants. Completed in 2 December 2015.

Timeline

6 March 2013

Primary endpoint
2 December 2015

2 December 2015

Quick facts

Lead sponsor	Centre hospitalier de l'Université de Montréal (CHUM)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	27
Start date	6 March 2013
Primary completion	2 December 2015
Estimated completion	2 December 2015
Sites	1 location across Canada

Drugs / interventions tested

• Topical probiotic treatment with Lactococcus lactis W136
• Saline irrigation — full drug profile →

Conditions studied

• Chronic Rhinosinusitis — all drugs for Chronic Rhinosinusitis →

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Who can join

Adults 18 to 65, any sex, with Chronic Rhinosinusitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Engineered Lactococcus lactis secreting Flt3L and OX40 ligand for in situ vaccination-based cancer immunotherapy.
   Zhu J, Ke Y, Liu Q, Yang J, et al · · 2022 · cited 82× · PMID 36463242 · DOI 10.1038/s41467-022-35130-7
2. Intranasal Application of <i>Lactococcus lactis W136</i> Is Safe in Chronic Rhinosinusitis Patients With Previous Sinus Surgery.
   Endam LM, Alromaih S, Gonzalez E, Madrenas J, et al · · 2020 · cited 37× · PMID 33154953 · DOI 10.3389/fcimb.2020.00440
3. Intranodal injection of neoantigen-bearing engineered &lt;i&gt;Lactococcus lactis&lt;/i&gt; triggers epitope spreading and systemic tumor regressions.
   Zhu J, Sun Y, Qian X, Li L, et al · · 2025 · cited 4× · PMID 40486831 · DOI 10.1016/j.apsb.2025.02.041
4. Response to intranasal <i>Lactococcus lactis W136</i> probiotic supplementation in refractory CRS is associated with modulation of non-type 2 inflammation and epithelial regeneration.
   Al-Romaih S, Harati O, Mfuna LE, Filali-Mouhim A, et al · · 2023 · cited 4× · PMID 37007649 · DOI 10.3389/falgy.2023.1046684
5. Preliminary evaluation of the safety and efficacy of oral human antimicrobial peptide LL-37 in the treatment of patients of COVID-19, a small-scale, single-arm, exploratory safety study
   Zhang H, Zhao Y, Jiang X, Zhao Y, et al · · 2020 · cited 2× · DOI 10.1101/2020.05.11.20064584