study in patients with mild to moderate psoriasis

Conditions: Psoriasis

Summary: this was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot study to obtain data on size and variance of treatment effects in subjects with mild to moderate psoriasis.

this was a randomized, double blind,fixed dose, placebo controlled, parallel-group pilot study to obtain data on size and variance of treatment effects in subjects with mild to moderate psoriasis. the target sample size of 60 was selected as a practical figure for recruitment purposes in one centre over 3 months.after a 2 week washout during which only emollients were applied to their psoriasis, patients attended for baseline assessment of psoriasis severity and blood tests.subjects attended every 4 weeks for 12 weeks for clinical assessment and blood tests.each patient once eligible{see inclusion \& exclusion criteria} was allocated to either active treatment or placebo in identical packing for a total of 12 weeks.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with mild to moderate psoriasis as defined by the clinician, * has a psoriasis area and severity index{pasi} of less than 20, * male or female subjects, * aged between 18-60 years of age, * non-pregnant female and must agree to use adequate method of contraception during the study, * is capable of giving written informed consent prior to study entry, * be willing to refrain from taking dietary supplements or other foods that contain fermented live bacteria within 1 month prior to treatment and during the study, * have not participated in a clinical drug study or used an investigational new drug during the past previous 30 days, * clinical chemistry and haematology results from visit 1 are within normal limits, * be willing to refrain from using any topical psoriactic cream 2 weeks prior to treatment and during the study. exclusion criteria: * are less than 18 years of age, and not more than 60 years of age, * history of sensitivity to lactose \[eg, lactose intolerance\] or other dairy products, * history of consumption of probiotics,1 month prior to treatment, * being treated with steroids 2 weeks prior to entry, diseases of the gastrointestinal tract,liver,pancreas and biliary tree\[eg;gastritis,symptomatic gall stones,duodenal ulcer,gastroenteritis,diverticulitis.\] exceptions include haemorrhoids,hiatus hernia and asymptomatic gall stones. * history of major gastric,hepatic,pancreatic or intestinal surgery or perforation,excluding cholescystectomy,appendicectomy,haemorrhoidectomy or polypectomy. * recent unexplained rectal bleeding and/or significant unexplained weight loss. * antibiotic use within one month prior to visit 1. have a significant acute or chronic coexisting illness{cardiovascular,gastrointestinal,immunological}or a condition, which contraindicates,in the investigators judgement entry to the study. * patients with diabetes mellitus. * individuals who, in the opinion of the investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the trial. * subjects currently receiving treatment involving experimental drugs. * if a subjects has been in a recent experimental trial,must be not less than 30 days prior to this study. * have a concomitant end stage organ disease eg; cardiovascular,hepatic,pulmonary,renal,which , in the investigators judgement,contraindicates participation in the study. * have a history of malignancy in the past 5 years with the exception of basal cell carcinoma. * evidence of alcohol or drug abuse. * evidence of unstable forms of psoriasis,including guttate, erthrodermic , exfoliative or pustular psoriasis. * evidence of other inflammatory skin disease that may confound the evaluation of psoriasis. * has had systematic antipsoriatic treatment or puva therapy within the previous 4 weeks. * subject who has had uvb therapy with the previous 2 weeks. * if the subjects scores \>20% on the pasi.

Keywords: pilot study