Oral Delivery of a Probiotic Induced Changes at the Nasal Mucosa of Seasonal Allergic Rhinitis Subjects after Local Allergen Challenge: A Randomised Clinical Trial

Abstract

ObjectiveTo determine effects of probiotic consumption on clinical and immunological parameters of seasonal allergic rhinitis (SAR) in an out-of-season single nasal allergen challenge.MethodsIn a study registered at ClinicalTrials.Gov (NCT01123252), a 16-week dietary intervention was undertaken in 60 patients with allergic rhinitis (>16 years old). Using a double-blinded, placebo-controlled anonymised design, the patients were divided equally into two groups. One group was given a dairy drink containing Lactobacillus casei Shirota to ingest daily while the other consumed a similar drink without bacteria. Participants attended the clinic on two consecutive days before the intervention and then again at the end of the study period. On the first day of each 2-day visit, following clinical examination, assessments were made of total nasal symptoms scores and peak nasal inspiratory flow. Nasal scrapings, nasal lavage and blood were collected for laboratory analyses of cellular phenotypes, soluble mediator release and in vitro responses to pollen allergen. These procedures were repeated 24 hours following nasal allergen challenge.ResultsPrior to and following intervention there were no detectable differences between study groups in measured clinical outcome. After intervention, there were differences between groups in their percentages of CD86+ epithelial cells (p = 0.0148), CD86+CD252+ non-epithelial cells (p = 0.0347), sIL-1RII release (p = 0.0289) and IL-1β (p = 0.0224) levels at the nasal mucosa. Delivery of probiotic also suppressed production of sCD23 (p = 0.0081), TGF-β (p = 0.0283) and induced increased production of IFN-γ (p = 0.0351) in supernatants of cultured peripheral blood.Conclusions & Clinical RelevanceThis study did not show significant probiotic-associated changes with respect to the primary clinical endpoint. An absence of overt clinical benefit may be due to an inability of single nasal challenges to accurately represent natural allergen exposure. Nevertheless, oral delivery of probiotics produced changes of the immunological microenvironment at the nasal mucosa in individuals affected by SAR.Trial RegistrationClinicalTrials.Gov NCT01123252

A significant decrease in the gene expression of interleukin-17 following the administration of synbiotic in patients with allergic rhinitis who underwent immunotherapy: A placebo-controlled clinical trial

“…studies that evaluated IL-4 cytokine level in serum, nasal mucosal secretions, and supernatants of PBMCs cultures. [1622] However, significant reduction of IL-5 and IL-13 in studies of Singh et al . and IL-13 in Chen et al .…”

Nutritional Modulation of Immune Function: Analysis of Evidence, Mechanisms, and Clinical Relevance

“…In a small pilot study conducted in individuals with seasonal allergic rhinitis ( n = 10/group), Ivory et al found that participants receiving Lactobacillus casei Shirota drink for 5 mo had lower antigen-induced production of IL-5, IL-6, and IFN-γ in PBMC, as well as increased IgG and decreased IgE levels in serum compared to the placebo group; however, no difference in clinical symptoms was observed (222). In a later trial with similar design but larger sample size and more comprehensive outcome measures, the same group found difference between probiotics and control groups in several immunologic parameters suggesting favorable effect of probiotics on allergy, however, they once again failed to detect difference in primary effect on clinical endpoints (223). By viewing many other trials which demonstrated mixed results, it is reasonable to conclude that evidence is lacking to support the beneficial effect of probiotics on allergy at present.…”

Microbiome and Allergic Diseases

“…Some investigations have shown that the oral administration of probiotics may benefit allergic rhinitis patients ( 108 – 110 ); similarly, local nasal administration of Lactococcus lactis NZ9000 can affect local and systemic immune responses against S. pneumoniae ( 111 ). However, Ivory et al reported that even oral delivery of Lactobacillus casei Shirota modified the immune system of allergic individuals ( 110 ), these modifications did not have a significant impact on the allergic status ( 112 ), highlighting the fact that analysis of immune parameters per se is not a real indicator of the therapeutical properties of the probiotics.…”