Verminderung der Rezidivhäufigkeit bei Patienten mit chronisch rezidivierender hypertrophischer Sinusitis unter Behandlung mit einem bakteriellen Immunstimulans (Enterococcus faecalis-Bakterien humaner Herkunft)

Abstract

A double-blind, placebo-controlled multicenter study in 157 patients with chronic recurrent sinusitis investigated the occurrence of acute relapses during treatment of patients with a bacterial immunostimulant (3 x 30 drops/day), comprised of cells and autolysate of human Enterococcus faecalis bacteria (Symbioflor 1, n = 78) in comparison to placebo (n = 79). The study included a treatment period of 6 months and a follow-up period of 8 months. Under verum the occurrence of relapses (50 incidents) was about half (56%) the number observed under placebo (90 incidents). In the Kaplan-Meier test the verum preparation emerged as significantly superior (p = 0.045, log rank test) compared to placebo. This superiority of verum was found during the treatment period with 17 vs. 33 relapses (p = 0.019) as well as during the follow-up observation with 33 vs. 57 relapses (p = 0.013). The time interval to the first relapse was clearly longer under verum (513 days) than under placebo (311 days). The relative risk for a relapse under the test preparation compared to placebo was 49.0% during the treatment and 55.8% during the follow-up period. Severity of the acute relapses was comparable in both groups. However, antibiotic therapy was only required in 2 patients treated with verum compared to 6 patients in the placebo group. Both preparations were well tolerated and serious side effects did not occur in either group. No changes in laboratory tests--hematology and clinical chemistry--were observed. Potential immunomodifying effects of the test preparation in view of the significant reduction in relapses were discussed.

Clinical Detection of Chronic Rhinosinusitis through Next-Generation Sequencing of the Oral Microbiota

“…In contrast to antibiotics, probiotics can reverse the diversity of the sinus microbiome [ 54 ]. Oral probiotic administration is beneficial in treating CRS [ 55 ], reducing colonization of pathogenic species [ 56 ], and preventing upper respiratory tract infections [ 57 ]. These studies indicated the important roles of dental hygiene and oral microbiome in CRS.…”

The microbiome and chronic rhinosinusitis

“…The use of oral Enterococcus faecalis showed benefit in treating CRS and recurrent acute rhinosinusitis in two studies. 65 , 66 The benefit was seen to last for up to 8 months in one randomized study in which probiotic was administered for 6 months. 65 Although the use of probiotics is well described in gastrointestinal research, the use in CRS remains limited.…”

Enterococcus durans EP1 a Promising Anti-inflammatory Probiotic Able to Stimulate sIgA and to Increase Faecalibacterium prausnitzii Abundance

“…Now, probiotics can be considered as a therapeutic option for treatment of allergy and even for inducing or maintaining clinical remission of IBS. E. faecalis Symbioflor 1, an immunomodulatoty strain, has been used to combat recurrent, chronic sinusitis or bronchitis and to help to asthma treatment in school children ( 22 , 23 ). E. faecium Paraghurt ® has demonstrate its efficacy in lowering the symptoms associated with IBS in a clinical study ( 24 ) as well as E. faecium PR88 ( 25 ) and the multi-strains probiotic ProSymbioflor ® ( E. faecalis and E. coli ) ( 26 ).…”