Research on the efficacy of prophylactic use of Acidosalus® probiotic in women with recurrent cystitis

Abstract

Cilj ovog prospektivnog ispitivanja bio je ispitati djelotvornost profilaktičke primjene probiotika Acidosalusa® u žena s rekurentnim cistitisom. Acidosalus® je jedinstvena kombinacija Lactobacillus acidophilus, Lactobacillus rhamnosus i bifidobakterija u visokim terapijskim koncentracijama živih bakterija spremnih za razmnožavanje. Sadrži nadalje vitamine B skupine, folnu kiselinu, lako topive laktate, kalij, željezo, fosfor, te ima mogućnost stvaranja antimikrobnih supstanci - mliječne i octene kiseline, diacetila, laktocidina, acidofilucina, acidocina i acidofilina. Ispitivanje je provedeno u Ambulanti za urogenitalne infekcije Klinike za infektivne bolesti „Dr. Fran Mihaljević“ u Zagrebu u razdoblju od 01.01.2006. do 31.12.2009. godine. Ispitivano je 117 bolesnica u dobi od 18 do 65 godina s dijagnozom rekurentnog cistitisa - s više od dvije epizode cistitisa u posljednjih 6, odnosno više od 3 epizode u posljednjih 12 mjeseci. Uvjeti za uključivanje su bili: prisutnost simptoma infekcije donjeg urotrakta (dizurija, polakizurija, urgencija), identičan mikrobiološki nalaz obriska rodnice i urinokulture, leukociturija, te ultrazvukom isključena abnormalnost mokraćnog sustava. Sve su bolesnice kroz 7 dana liječene adekvatnom antimikrobnom terapijom, a zatim su nasumce podijeljene u dvije skupine. U jednih je odmah po prestanku antimikrobne terapije primijenjena profilaksa s probiotikom Acidosalus® te su kroz najmanje tri mjeseca kontinuirano uzimale peroralno Acidosalus® uz istovremenu vaginalnu primjenu Acidosalus® vaginaleta kroz najmanje 7 dana. Planirana primjena profilakse bila je 3 mjeseca. Na kontroli 1-2 tjedna nakon završene sedmodnevne antimikrobne terapije, sve su bolesnice bile klinički i bakteriološki izliječene. Do kontrole 3 mjeseca nakon završene sedmodnevne antimikrobne terapije u skupini od ukupno 56 žena koje su primale profilaksu probiotikom rekurentne epizode cistitisa imalo je njih 3 (5,4%), a u skupini od ukupno 61 žene koje nisu primale profilaksu broj rekurentnih epizoda bio je 11 (18,3%). Tri mjeseca nakon završene 7-dnevne antimikrobne terapije uropatogene bakterije su dokazane češće u rodnici žena koje nisu primale profilaksu probiotikom (u 44 od ukupno praćenih 50 bolesnica - 88%) nego u žena koje su primale profilaksu probiotikom (u 18 od ukupno 53 bolesnica - 34%). Rezultati ove studije pokazuju da je profilaktička primjena mješovite kulture probiotika sadržane u medicinskom proizvodu Acidosalus® u žena s rekurentnim uroinfekcijama djelotvorna i sigurna. Ističemo važnost istovremene oralne i vaginalne primjene, čime se uspostavlja obnavljanje i poboljšanje funkcije autohtone mikroflore crijeva i rodnice, smanjuje rezervoar uropatogenih bakterija u crijevu i jača imunitet općenito.The aim of this prospective research was to investigate the efficacy of prophylactic use of probiotic Acidosalus® in women with recurrent cystitis. Acidosalus® is a unique combination of Lactobacillus acidophilus, Lactobacillus rhamnosus and bifidobacteria in high therapeutic concentrations of live bacteria ready for multiplication. It consists of group B vitamins, folic acid, highly soluble lactates, potassium, iron, phosphorus, and has the possibility to produce antimicrobial substances - lactic and acetic acid, diacetyl, lactocidine, acidophilucin, acidocin and acidophylin. The research was conducted at the Outpatient Department for Urogenital Infections of the University Hospital for Infectious Diseases „Dr. Fran Mihaljević“ in Zagreb in the period between 01.01.2006. until 31.12.2009. We investigated 117 patients aged between 18 and 65 years with diagnosed recurrent cystitis – more than two episodes of cystitis in the past 6, i.e. more than three episodes in the past 12 months. The inclusion criteria were as follows: presence of symptoms of lower urinary tract infection (dysuria, polakisuria, urgency), identical microbiological finding of cervical swab and urinary culture, leukocyturia, ultrasound excluded urinary tract abnormality. All patients received adequate antimicrobial therapy for 7 days and then were randomly divided into two groups. One group received Acidosalus® probiotic as a prophylaxis immediately after the end of antimicrobial therapy – and at least three months continuously received Acidosalus® orally with simultaneous vaginal administration of Acidosalus® vaginalettes for at least 7 days. Planned duration of prophylaxis was three months. Follow up visit performed 1-2 weeks after completion of seven day course of antimicrobial therapy showed that all patients were clinically and bacteriologically cured. Until the follow up visit three months after completed 7-day antimicrobial therapy, recurrent episodes of cystitis were recorded in 3 (5,4%) out of a total of 56 women who received probiotic prophylaxis and in 11 (18,3%) out of a total of 61 women who did not receive probiotic prophylaxis. Three months after completed 7-day course of antimicrobial therapy, uropathogen bacteria were more often detected in vagina of women who did not receive probiotic prophylaxis (in 44 out of a total of 50 monitored patients - 88%) than in women who did not receive probiotic prophylaxis (in 18 out of a total of 53 patients - 34%). The results of this study have shown that prophylactic use of mixed probiotic culture present in medicinal product Acidosalus® in women with recurrent urinary tract infections is efficient and safe. We would like to stress the importance of simultaneous oral and vaginal application, by which we achieve regeneration and improved function of autochthonous intestinal and vaginal microflora, reduce a reservoir of uropathogen bacteria in intestines and boost immunity in general