Dataset Information

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

ABSTRACT: Objective: Modulation of the dysbiotic gut microbiome with "healthy" bacteria via a stool transplant or supplementation is increasingly practiced, however this approach has not been explored in the nasal passages. We wished to verify whether Lactococcus lactis W136 (L. lactis W136) bacteria could be safely applied via irrigation to the nasal and sinus passages in individuals with chronic rhinosinusitis (CRS) with previous undergone endoscopic sinus surgery, and whether this was accompanied by bacterial community flora modification. Study Design: Prospective open-label pilot trial of safety and feasibility. Setting: Academic tertiary hospital center. Subjects and Methods: Twenty-four patients with CRS refractory to previous medical and surgical therapy received a 14-day course of BID sinus irrigations containing 1.2 × 109 CFU live L. lactis W136. Patients were monitored for safety using questionnaire, sinus endoscopy, otoscopy, UPSIT-40 smell testing, and endoscopically-obtained conventional sinus culture and a swab for 16S microbiome profiling. Results: All 24 patients receiving at least one treatment successfully completed treatment. L. lactis W136 probiotic treatment was safe, with no major adverse events or new infections. Treatment was associated with improvement in sinus symptoms, QOL, and mucosal scores, which remained improved during the subsequent 14-day observation period. Microbiome changes associated with treatment were limited to an increase of the pathobiont Dolosigranulum pigrum, a bacteria identified as potentially beneficial in the upper airways. Subgroup analysis suggested differences in microbiomes and responses for CRSsNP and CRSwNP phenotypes, but these did not attain significance. Conclusion: Intranasal irrigation of live L. lactis W136 bacteria to patients with refractory chronic rhinosinusitis was safe, and was associated with effects on symptoms, mucosal aspect and microbiome composition. Intranasal bacteria may thus find a role as a treatment strategy for CRS. Clinical Trials Registration: www.ClinicalTrials.gov. identifier: NCT04048174.

SUBMITTER: Endam LM

PROVIDER: S-EPMC7586919 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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

Endam Leandra Mfuna LM Alromaih Saud S Gonzalez Emmanuel E Madrenas Joaquin J Cousineau Benoit B Renteria Axel E AE Desrosiers Martin M

Frontiers in cellular and infection microbiology 20201012

Objective: Modulation of the dysbiotic gut microbiome with "healthy" bacteria via a stool transplant or supplementation is increasingly practiced, however this approach has not been explored in the nasal passages. We wished to verify whether Lactococcus lactis W136 (L. lactis W136) bacteria could be safely applied via irrigation to the nasal and sinus passages in individuals with chronic rhinosinusitis (CRS) with previous undergone endoscopic sinus surgery, and whether this ...[more]

PMID: 33154953

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Project description:Patient-reported measures are designed to detect a true change in outcome, but they are also subject to change from biases inherent to self-reporting: changing internal standards, changing priorities, and changing interpretations of a given instrument. These biases are collectively known as "response shifts" and can obscure true change after medical interventions.To determine the presence of response shifts in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery.Multisite, prospective, observational cohort study conducted at academic tertiary care centers between February 2011 and May 2013. Study participants comprised a population-based sample of 514 adults (age ?18 years) with CRS, who elected surgical intervention for continuing medically refractory symptoms.Endoscopic sinus surgery.Preoperative and postoperative data from the 22-item Sinonasal Outcome Test (SNOT-22) survey instrument was characterized using exploratory factor analysis. Subsequent longitudinal structural equation models were estimated to test structure, potential response shifts, and true change in the SNOT-22 scores.A total of 339 participants (66.0%) provided survey evaluations at baseline and 6-month follow-up. Factor analysis of the SNOT-22 revealed 5 correlated, yet distinguishable, underlying factors. Endoscopic sinus surgery had a differential impact across these factors, with the largest effect size in rhinologic symptoms (mean [SD] SNOT-22 scores before and after surgery, 13.18 [5.11] and 7.37 [5.48], respectively; d?=?-1.13 [P?<?.001]) and extranasal rhinologic symptoms (8.31 [3.46] and 4.83 [3.68], respectively; d?=?-1.00 [P?<?.05]) (d is an effect size measure defined as the difference in means divided by the presurgery SD). Endoscopic sinus surgery had a smaller, yet significant, effect size on the remaining 3 factors: ear/facial symptoms (7.32 [4.6]) and 3.90 [4.07], respectively; d?=?-0.74 [P?<?.001]), psychological dysfunction (11.90 [7.21] and 6.50 [6.69], respectively; d?=?-0.75 [P?<?.05]), and sleep dysfunction (10.12 [5.59] and 5.88 [5.37], respectively; d?=?-0.76 [P?<?.001]). Participants were found to undergo recalibration, reprioritization, and reconceptualization of symptoms after intervention; however, the magnitude of these response shifts was small and not clinically significant.The SNOT-22 measures 5 distinct factors, not a single construct. Reporting of individual subscale scores may improve sensitivity of this instrument in future studies. Participants undergoing endoscopic sinus surgery experience only clinically insignificant response shifts, validating assessment of change through use of presurgery and postsurgery SNOT-22 responses.clinicaltrials.gov Identifier: NCT01332136.

Project description:BackgroundPsychological dysfunction is highly prevalent among patients with chronic rhinosinusitis (CRS). Previous study has identified various measures of anxiety and depression as predictors of quality-of-life outcomes following endoscopic sinus surgery (ESS). Psychological dysfunction scores, as measured by the 22-item Sino-Nasal Outcome Test (SNOT-22), have been found to influence treatment decision making in CRS. This study aims to further elucidate improvement in discrete psychological symptoms following ESS for CRS.MethodsAdult patients with medically recalcitrant CRS electing to undergo ESS were prospectively enrolled into a multi-institutional, observational cohort. Psychological-related symptom severity and postoperative outcomes were assessed using psychological domain items of the SNOT-22, including subgroup analysis of patients with and without comorbid depression.ResultsA total of 374 participants met inclusion criteria and were followed postoperatively for a mean ± standard deviation (SD) of 14.6 ± 5.0 months. Total mean psychological domain scores improved from 15.9 ± 8.2 to 8.5 ± 8.4 (p < 0.001). Significant relative mean improvements were reported in "waking up tired" (23%; p < 0.001), "fatigue" (25%; p < 0.001), "reduced productivity" (28%; p < 0.001), "reduced concentration" (27%; p < 0.001), " frustrated/restless/irritable" (27%; p < 0.001), "sad" (15%; p < 0.001), and "embarrassed" (8%; p < 0.001) scores. A total of 64% to 66% of participants reported improvement in "reduced productivity," "waking up tired," "fatigue," and "frustrated/restless/irritable," compared to 46% and 38% reporting improvement in "sad" and "embarrassed," respectively.ConclusionPatients with CRS report significant improvement in common mental health-related symptoms following ESS. Despite these improvements, some degree of persistent postoperative psychological dysfunction was reported. Further study is necessary to determine which factors are associated with persistent psychological dysfunction after ESS in order to optimize treatment outcomes.

Project description:BACKGROUND:Chronic rhinosinusitis (CRS) is one of the commonest chronic health problems among adults in the UK. Around 15% of CRS patients undergo functional endoscopic sinus surgery (FESS) annually after failing medical treatment. However, as incomplete resolution of symptoms or complications post-operatively is common, the post-operative management is considered to be as important as the surgery itself. A bioabsorbable corticosteroid-eluting sinus implant (CESI) (Propel®, mometasone furoate 370 µg) has been used as an alternative post-FESS treatment. OBJECTIVE:The objective of this study was to assess the cost effectiveness of the corticosteroid-eluting implant versus non-corticosteroid-eluting spacer following FESS for treatment of patients with CRS. METHODS:A decision tree model was developed to estimate the cost and effectiveness in each strategy. Costs and effects were estimated from a UK National Health Service (NHS) and personal social services perspective over a 6-month time horizon. Model pathways and parameters were informed by existing clinical guidelines and literature and sensitivity analyses were conducted to explore uncertainties in base-case assumptions. RESULTS:Over a 6-month time horizon, inserting CESI at the end of FESS is less costly (£4646 vs. £4655 per patient) and is the more effective intervention [total quality-adjusted life-years (QALYs) over 6 months 0.443 vs. 0.444] than non-corticosteroid-eluting spacers; hence, it is a dominant strategy. The probabilistic analysis results indicate that CESI following FESS has a 62% probability of being cost effective at the £20,000/per QALY willingness-to-pay threshold and 56% probability of being a cost-saving intervention. CONCLUSIONS:The use of CESI after FESS results in fewer post-operative complications than non-corticosteroid-eluting implants and may be a cost-saving technology over a 6-month time horizon. Although the cost of initial treatment with the CESI is greater, cost savings are made due to a reduction in the number of complications experienced.

Dataset Information

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

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Intranasal Application of <i>Lactococcus lactis W136</i> Is Safe in Chronic Rhinosinusitis Patients With Previous Sinus Surgery.

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