Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis

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.