Title:~Food supplementation with the probiotic preparation VSL#3 as a support to standard pharmaceutical therapy in patient with mild to moderate active Ulcerative Colitis. A double-blind, randomized, placebo controlled study.~Study Design:~Double blind, randomised, parallel groups, placebo controlled, multicentre, national study.~Study Period:~February 2006 - October 2007 (recruitment: 12 months; food supplementation with VSL#3: 8 weeks).~Study Population:~The study population will comprise 144 patients with mild to moderate active ulcerative colitis on top of standard pharmaceutical therapy. 72 patients will be randomised to receive food supplementation VSL#3 and 72 to receive placebo.~Total Number of centers:~Approximately 16~Study Objectives:~To assess the beneficial effects of food supplementation with VSL#3 in patients affected by mild to moderate active ulcerative colitis in a double-blind, placebo-controlled study.~Study product:~VSL#3 consists of sachets each containing 900 billion viable lyophilised bacteria, comprising 4 strains of Lactobacillus (L. paracasei, L. plantarum, L. acidophilus and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, B. breve and B. infantis) and 1 strain of Streptococcus thermophilus, in maltose and silicon dioxide as excipients.~The placebo is in the form of identical sachets containing only maltose and silicon dioxide.~The dose which will receive each patients is two sachets of VSL#3 or placebo to take twice a day orally (total amount of bacteria: 3.600 billion organisms per day).~Assessments:~Primary Outcome The primary outcome is the evaluation of the beneficial effects of food supplementation with VSL#3 in patients affected by UC, assessed by a decrease in the UCDAI of 50% or more, from baseline to week 8.~Secondary Outcomes:~Assessment of the beneficial effects of the food supplementation with the probiotic preparation VSL#3 on:~activity of ulcerative colitis.~change in subjective symptoms (rectal bleeding and stool frequency) from baseline to weeks 2, 4 and 8 of food supplementation with VSL#3.~lack of beneficial effects, defined by need for further food supplementation or inability to stay on study till week 8.~quality of life questionnaire (IBDQ)~concordance between the Physician and Patient Global Assessment Scale at each time point.~Physical Status Evaluations:~Assessment of haematological laboratory tests, vital signs (blood pressure, pulse rate and respiratory rate), medical history and physical examination.
This is a double-blind, randomized, placebo controlled study to assess the beneficial effects of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in patients affected by mild to moderate active ulcerative colitis.