Topical Probiotics for Sinusitis

Overseen By Victoria Lee, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Illinois at Chicago

Must not be taking: Topical antibiotics, Oral corticosteroids

Disqualifiers: Cognitive impairment, Terminal illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are taking topical antibiotic irrigations, you will need to stop them to participate in the trial. Additionally, you cannot have taken oral antibiotics or oral corticosteroids in the two weeks before joining the study.

What data supports the effectiveness of the treatment Isotonic Saline Solution, Lactobacillus sakei proBio65 for sinusitis?

Research on similar probiotics, like Lactococcus lactis W136, shows that intranasal application can improve sinus symptoms and quality of life in chronic rhinosinusitis patients by reducing harmful bacteria and increasing beneficial ones. This suggests that using probiotics in the nasal passages might help balance the bacteria and reduce inflammation, potentially benefiting sinusitis patients. ^{1 2 3 4 5}

Is the use of topical probiotics for sinusitis safe?

Research shows that using probiotics like Lactococcus lactis W136 and Lactobacillus sakei in the nasal passages is generally safe, with no major side effects or new infections reported in studies. These probiotics have been tested in people with chronic sinus issues and have shown to be well-tolerated. ^{2 4 5 6 7}

How does the treatment Lactobacillus sakei proBio65 for sinusitis differ from other treatments?

Lactobacillus sakei proBio65 is unique because it is a topical probiotic treatment that aims to restore balance in the nasal microbiome, potentially reducing inflammation and symptoms of sinusitis by promoting beneficial bacteria, unlike traditional treatments that often focus on antibiotics or anti-inflammatory drugs. ^{3 4 5 6 8}

What is the purpose of this trial?

The purpose of this randomized study will be to determine whether topical probiotic sinus irrigations are more effective compared to saline sinus irrigation controls in the treatment of active CRS in patients who have had prior sinus surgery based on subjective and objective outcome measures.

Research Team

Victoria Lee, MD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for adults over 18 with chronic sinusitis who've had sinus surgery at least 12 weeks before joining. They must have worsening symptoms like nasal blockage, discharge, facial pain, or loss of smell and visible issues on a sinus exam. Participants need to follow the study rules and give informed consent.

Inclusion Criteria

I have worsening sinus symptoms and changes seen in a sinus exam.

I had sinus surgery over 12 weeks ago and my sinuses are suitable for the trial.

Patients must be willing to follow study related procedures for the duration of the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Lactobacillus sakei or saline nasal irrigation, twice a day for 14 days

2 weeks

1 visit (in-person) before treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of sinonasal symptoms and microbiota

6 weeks

1 visit (in-person) immediately after treatment, 1 visit (in-person) 6 weeks after enrollment

Treatment Details

Interventions

• Isotonic Saline Solution
• Lactobacillus sakei proBio65

Trial Overview The study tests if Lactobacillus sakei probiotic irrigations are better than saline (saltwater) rinses in treating chronic sinusitis after prior surgery. It's randomized: patients don't choose which treatment they get.

Participant Groups

Group I: Lactobacillus sakei nasal irrigation Experimental Treatment 1 Intervention

Patients will perform nasal irrigation with Lactobacillus sakei, using a 240ml NeilMed sinus rinse bottle, 2 times/day for 14 days. A blinded packet provided by IDS containing a premeasured amount of Lactobacillus sakei to be mixed with 240ml of distilled water will be provided to patients for each irrigation.

Group II: Saline Nasal Irrigation (Control) Active Control 1 Intervention

Patients will perform nasal irrigation with an isotonic saline solution, using a 240ml NeilMed sinus rinse bottle, 2 times/day for 14 days. A blinded packet supplied by IDS containing a premeasured amount of saline to be mixed with 240ml of distilled water will be provided to patients for each irrigation.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Cures Within Reach

Collaborator

Trials

25

Recruited

2,100+

Findings from Research

In a study involving 77 patients with chronic inflammatory rhinosinusitis, the probiotic Lactobacillus rhamnosus R0011 showed a significant improvement in quality of life at 4 weeks, but this effect did not persist at 8 weeks.

Overall, there were no significant differences in quality of life improvements or symptom frequency between the probiotic and placebo groups, indicating that the probiotic did not provide a meaningful benefit over placebo in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial. Mukerji, SS., Pynnonen, MA., Kim, HM., et al.[2022]

In a study involving 24 patients with chronic rhinosinusitis (CRS) who did not respond to surgery, the use of the probiotic Lactococcus lactis W136 for 14 days showed significant improvements in sinus symptoms and mucosal health, as well as changes in the sinus microbiome.

Transcriptomic analysis revealed that the treatment influenced gene expression related to immune regulation and epithelial cell function, suggesting that targeting the sinus microbiome and epithelium could be a promising therapeutic approach for CRS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to intranasal Lactococcus lactis W136 probiotic supplementation in refractory CRS is associated with modulation of non-type 2 inflammation and epithelial regeneration. Al-Romaih, S., Harati, O., Mfuna, LE., et al.[2023]

Topical probiotics may help modify symptoms of chronic rhinosinusitis (CRS) by restoring the balance of the nasal microbiome, which is often disrupted in patients with this condition.

While probiotics have shown some efficacy in treating other conditions like otitis media and tonsillitis, there is currently limited clinical evidence for their effectiveness in CRS, highlighting the need for more targeted clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential for Topical Probiotic Treatment of Chronic Rhinosinusitis, a Personal Perspective. Cervin, AU.[2018]

Two gram-positive probiotic strains were found to effectively induce interleukin-10 (IL-10) secretion in immune cells, which could help reduce inflammation in patients with chronic rhinosinusitis (CRS).

The probiotics were shown to be well-tolerated by sinus epithelial cells, indicating their safety for potential use as a novel topical treatment for CRS, warranting further clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical probiotics as a therapeutic alternative for chronic rhinosinusitis: A preclinical proof of concept. Schwartz, JS., Peres, AG., Mfuna Endam, L., et al.[2017]

A pilot trial involving 24 patients with chronic rhinosinusitis showed that nasal irrigation with the probiotic Lactococcus lactis W136 was safe, with no major adverse events reported during the 14-day treatment period.

Patients experienced improvements in sinus symptoms and quality of life, suggesting that intranasal probiotics could be a promising treatment strategy for chronic rhinosinusitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intranasal Application of Lactococcus lactis W136 Is Safe in Chronic Rhinosinusitis Patients With Previous Sinus Surgery. Endam, LM., Alromaih, S., Gonzalez, E., et al.[2021]

Lactobacillus sakei HEM 224, isolated from kimchi, was found to be safe with no hemolysis, biogenic amine production, or transferable antibiotic resistance, making it a promising probiotic strain.

In animal models, L. sakei HEM 224 improved conditions in both colitis and allergic airway inflammation by enhancing epithelial barrier integrity and modulating the immune response, suggesting its potential for treating inflammatory diseases in the gut and respiratory tract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifunctional effects of Lactobacillus sakei HEM 224 on the gastrointestinal tract and airway inflammation. Kim, HS., Oh, H., Kim, B., et al.[2023]

Probiotics showed a lower risk of symptom relapse in patients with chronic rhinosinusitis, with significant reductions in relapse rates during and up to 8 months post-treatment, indicating potential long-term benefits.

While probiotics were associated with some mild adverse effects like epistaxis and abdominal pain, they did not significantly improve overall symptoms or quality of life measures within the first 8 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of probiotics in chronic rhinosinusitis: a systematic review of randomised, controlled trials. Fong, P., Lim, K., Gnanam, A., et al.[2023]

Lactobacillus sakei probio 65, a probiotic isolated from kimchi, effectively improved allergic dermatitis in mice induced by a chemical allergen, showing a faster recovery compared to control mice.

The probiotic demonstrated its efficacy by reducing levels of immunoglobulin E (IgE) and interleukin-4 (IL-4), which are associated with allergic responses, indicating its potential as a treatment for allergic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New functional probiotic Lactobacillus sakei probio 65 alleviates atopic symptoms in the mouse. Park, CW., Youn, M., Jung, YM., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Response to intranasal Lactococcus lactis W136 probiotic supplementation in refractory CRS is associated with modulation of non-type 2 inflammation and epithelial regeneration. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential for Topical Probiotic Treatment of Chronic Rhinosinusitis, a Personal Perspective. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Topical probiotics as a therapeutic alternative for chronic rhinosinusitis: A preclinical proof of concept. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Intranasal Application of Lactococcus lactis W136 Is Safe in Chronic Rhinosinusitis Patients With Previous Sinus Surgery. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Multifunctional effects of Lactobacillus sakei HEM 224 on the gastrointestinal tract and airway inflammation. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Role of probiotics in chronic rhinosinusitis: a systematic review of randomised, controlled trials. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

New functional probiotic Lactobacillus sakei probio 65 alleviates atopic symptoms in the mouse. [2020]