Topical Probiotics for Sinusitis

Overseen By Anthony I Dick, MBBS, MPH

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a topical probiotic, specifically Lactobacillus sakei, can treat chronic sinusitis (CRS) more effectively than regular saline rinses. The goal is to determine if probiotic sinus rinses can improve symptoms such as nasal congestion, discharge, and facial pain in individuals who have previously undergone sinus surgery. Participants should have active CRS symptoms and have had sinus surgery at least a year prior. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using probiotics like Lactobacillus sakei in nasal rinses is generally safe. Studies have found no major side effects from using these probiotics in the nose, indicating that most people tolerate the treatment well. Testing of these probiotics in the nasal area has not reported serious problems. However, as with any treatment, some people might experience mild or temporary discomfort. Always consult a healthcare provider if concerns arise. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for sinusitis?

Unlike the standard treatments for sinusitis, which often include antibiotics or steroid nasal sprays, Lactobacillus sakei nasal irrigation offers a unique approach by utilizing beneficial bacteria to potentially restore balance in the nasal microbiome. This treatment involves a new active ingredient, Lactobacillus sakei, a probiotic that may help reduce inflammation and support the body's natural defenses against sinus infections. Researchers are excited about this method because it targets the root cause of sinusitis without relying on antibiotics, which can lead to resistance or side effects. Additionally, the probiotic is administered directly to the nasal passages, which may enhance its effectiveness and offer quicker relief.

What evidence suggests that this trial's treatments could be effective for sinusitis?

Research has shown that Lactobacillus sakei, which participants in this trial may receive, might help treat sinusitis by balancing nasal bacteria. Studies have found that using probiotics in the nose can reduce harmful bacteria that cause inflammation, potentially alleviating symptoms of chronic rhinosinusitis (CRS). Early results suggest these treatments are safe and well-tolerated, with no major side effects reported. Although more research is needed, these initial findings offer promise for those seeking new ways to relieve sinus issues. Participants in this trial may also receive saline nasal irrigation as a control treatment. ^{1 3 4 5 6}

Who Is on the Research Team?

Victoria Lee, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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

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

Patients must understand the purpose and procedures and be willing to sign the study informed consent document.

All adult men and women with active CRS will be considered for participation in this study without regard to race, gender, or socioeconomic status.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05427695

NCT05427695 | Topical Probiotic Sinus Irrigations for ... The purpose of this randomized study will be to determine whether topical probiotic sinus irrigations are more effective compared to saline sinus irrigation ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8701913/

The Role of Probiotics in Chronic Rhinosinusitis Treatment Probiotics have been extensively studied as a therapy for dysbiosis and inflammatory pathologies of various parts of the body.

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05427695/

Trial | NCT05427695 The purpose of this randomized study will be to determine whether topical probiotic sinus irrigations are more effective compared to saline sinus irrigation ...

4. withpower.com withpower.com/trial/topical-probiotics-for-sinusitis-68902

Topical Probiotics for Sinusitis 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12112188/

Nasal Rinsing with Probiotics—Microbiome Evaluation in ... Conclusions: Probiotic nasal rinses may contribute to restoring microbial homeostasis by reducing genera associated with inflammatory dysbiosis ...

6. mdpi.com mdpi.com/2077-0383/14/10/3341

Nasal Rinsing with Probiotics—Microbiome Evaluation in ... Two murine studies have shown a protective effect of locally administered probiotics against pathogen-mediated sinonasal inflammation [8,26,35], and some ...