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Australian Journal of Pharmacy : April 2005
cover story AN AJP/VRI BIOMEDICAL ADVERTORIAL Scientific evidence behind new proTract for Atopic Dermatitis A successful Australian trial is expected to pave the way towards increased use of a specific strain of probiotic—VRI Biomedical’s PCC Lactobacillus fermentum—in the treatment of atopic dermatitis in infants Now you can treat and relieve infant atopic dermatitis with a simple capsule T HE links between the immune system, the microbial world, the hygiene hypothesis and the Atopic Triad have been further underlined following an Australian trial of the probiotic strain, PCC Lactobacillus fermentum, that demonstrated its value in the treatment of atopic dermatitis, or allergic eczema, in infants. The PCC Lactobacillus fermentumprobiotic has been commercialised by VRI Biomedical* under the brand proTract for Atopic Dermatitis. Conducted at Perth’s Princess Margaret Hospital, the randomised, double-blind, placebo controlled trial (n=56 infants aged 6 to 18 months with moderate-to-severe atopic dermatitis) demonstrated that those on the proTract active ingredient for eight weeks were more likely to experience improvements in comparison to the placebo (92 per cent and 63 per cent respectively) after 16 weeks.1 Furthermore, only the subjects on the proTract active experienced significant reduction in the extent and severity of atopic dermatitis.1 Two months after ceasing treatment, long-lasting persistent benefits were also documented.1 proTract for Atopic Dermatitis had significantly lower respiratory tract infections as reported by parents,1 Furthermore, children taking compared to the placebo (46 per cent and 74 per cent respectively), and were more than twice as likely to report an improvement in quality of life.1 Hygiene hypothesis According to lead researcher, Associate Professor Susan Prescott, head of paediatrics and child health at the University of WA, there is a belief and a growing body of evidence that links an increase in the incidence of atopic diseases with changing patterns of infectious diseases within infants and efforts to create for them a more hygienic environment. This belief is typically called the hygiene hypothesis. ‘We live in harmony with the microbial environment. But are we missing out on the variety and magnitude of microbes, such as bacteria, that help to develop and mature our immune systems?’ questioned Associate Professor Prescott. ‘Early events are critical to the development of a mature 236 ? THE AUSTRALIAN JOURNAL OF PHARMACY VOL.86 APRIL 2005 Who can use it: Infants older than six months and children suffering from mild-to-severe atopic dermatitis. How to use it: One billion cfu per capsule twice daily for eight weeks or until symptoms improve. If symptoms recur, repeat treatment program. Open capsule and sprinkle contents onto food or drink to administer one dose. immune system—if anything goes wrong with the immune system it is likely to occur early on in our lives,’ she said. ‘Colonisation of the gut with a normal flora of bacteria, such as that delivered by probiotics, may be the key to assisting children who are prone to abnormal development of the immune system.’ Delivering good science Associate Professor Prescott said that in her study on moderate-to-severe dermatitis, proTract’s active ingredient seemed to have an accelerated or pronounced effect on the body’s ability to deal with the dermatitis. ‘This is good science,’ she said. ‘Dermatitis is a complex multifactorial condition and from the results of the study, it appears PCC Lactobacillus fermentumdelivers benefits to