Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis

ConditionChronic Rhinosinusitis (Diagnosis)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Illinois at Chicago

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients 18 years of age or older.

Patients diagnosed with acute exacerbation of CRS, defined by worsening of 1 or more sinonasal symptoms (nasal obstruction/congestion, nasal discharge, facial pain/pressure, reduced sense of smell) and inflammatory and/or infectious changes on sinus endoscopy.

Patients that have undergone functional endoscopic sinus surgery > 12 months prior to enrollment as documented in the patients electronic medical record, with patent sinuses deemed suitable for trial on investigator's discretion.

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

Disqualifiers

Patients who are taking topical antibiotic irrigations and are unwilling to stop them.

Patients who are unable to complete self-administered questionnaires because of cognitive impairment, language barrier, or severe medical conditions.

Patients who have a terminal illness (malignancy), immunocompromised (medication-related immunosuppression, immunodeficiency disorder) or systemic disease (granulomatosis polyangiitis or other autoimmune disease with sinonasal manifestations, cystic fibrosis), or recent head/sinonasal trauma that may predispose to infectious complications.

Patients who have severe or emergent complications from CRS or presence of a sinus tumor.

Trial design

Design model

Parallel

Treatments tested in this trial

Lactobacillus sakei proBio65
Drug
Lanto Sinus probiotic Lactobacillus sakei is a currently available over the counter supplement from the common source kimchi and produced in South Korea. Patients will be instructed to mix 1 packet with lukewarm distilled or boiled water in 240mL NeilMed® sinus rinse bottle.
Isotonic Saline Solution
Other intervention
Saline sinus irrigations (SAL group): NeilMed® Isotonic Sinus Rinse™ is marketed as a saline sinus irrigation formula. Subjects will be given instructions to mix one unlabeled packet (containing NeilMed® premixed buffered salt powder) with lukewarm distilled or boiled water in 240mL NeilMed® sinus rinse bottle.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Saline Nasal Irrigation (Control)Active comparator 1 intervention

Group B: Lactobacillus sakei nasal irrigationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Sinonasal Outcome Test-22 (SNOT-22)

It is expected that topical probiotic irrigations will result in a clinically significant change in symptom severity score (SNOT-22) (a change of 9 on a scale 0-110) compared to saline irrigations (primary outcome).

Time frame

6 weeks

Secondary outcomes

Sinus microbiota

Nasal swab samples will be assessed for the number of bacteria present before and after treatment. Bacterial DNA will be extracted from nasal swabs. The purified DNA will be quantified for concentration using a Qubit fluorometer (Invitrogen, CA, USA) before storing at -20°C until further use. Bacterial burden will be determined by quantitative PCR (qPCR) using universal 16S ribosomal RNA primers. Additionally, each nasal swab will be assessed for bacteria taxonomic distribution by NGS using the MiSeq NGS platform (Illumina) before and after treatment. MiSeq paired-end sequencing of the hypervariable V3-V4 regions of the 16S rRNA gene (primers 341F/785R) will be performed.

Time frame

6 weeks

Other outcomes

Lund-Kennedy Score

It is expected that topical probiotic irrigations will result in lower scores than sinus irrigations based on the Lund-Kennedy (LK) Endoscopic Scoring System. The LK system is used to evaluate sinus polyps, edema, discharge scarring and crusting. Scores range from 0 to 20. Lower scores mean a better outcome.

Time frame

6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

Cures Within Reach

Collaborator

Source ClinicalTrials.gov

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