title: VSL#3 induces and maintains short-term clinical response in patients with active microscopic colitis: a two-phase randomised clinical trial.
abstract: BACKGROUND
  The probiotic mixture VSL#3 has proven efficacious in inflammatory bowel diseases and irritable bowel syndrome; however, its efficacy in microscopic colitis (MC) is being investigated.
  
  
  OBJECTIVE
  To evaluate the safety and efficacy of a multistrain probiotic, VSL#3, in inducing clinical remission and achieving clinical response, as compared with mesalamine, in patients with active MC.
  
  
  METHODS
  A randomised, open labelled study comparing the efficacy of 900 billion colony-forming units/day of VSL#3 (group (Gp) A) or 1.6 g of mesalamine/day (Gp B) for 8 weeks in 30 patients with MC was conducted. After a washout period of 2 weeks, Gp B received 8 weeks of VSL#3 and Gp A was off medication for the next 8 weeks. The primary end points were clinical remission and clinical response at 8 weeks.
  
  
  RESULTS
  Of 30 patients, 15 were randomised in each arm. 11 patients in Gp A and 13 patients in Gp B completed 8 weeks of treatment. 5 (46%) of 11 patients in Gp A and 1 (8%) of 13 patients in Gp B attained clinical remission (p=0.022). Clinical response was seen in Gp A, as evidenced by a lower stool weight (377.6±104.5 g) as compared with Gp B (507±168.2 g; p=0.03). VSL#3 was effective in maintaining clinical response up to 10 weeks, even after discontinuation of therapy. Secondary end points like stool parameters, histology and well-being improved in both treatment groups.
  
  
  CONCLUSIONS
  The probiotic VSL#3 was found to offer the benefit of inducing as well as maintaining short-term clinical response in patients with active MC.
  
  
  BACKGROUND
  The clinical trial is registered with CLINICAL TRIAL REGISTRY INDIA; http://ctri.nic.in, CTRI No. "CTRI/2008/091/000086" (registered on: 23/06/2008).
authors.affiliation: Department of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
authors.forename: Sarika
authors.initials: S
authors.lastname: Rohatgi
authors.affiliation: Department of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
authors.forename: Vineet
authors.initials: V
authors.lastname: Ahuja
authors.affiliation: Department of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
authors.forename: Govind K
authors.initials: GK
authors.lastname: Makharia
authors.affiliation: Department of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
authors.forename: Tarun
authors.initials: T
authors.lastname: Rai
authors.affiliation: Department of Pathology , All India Institute of Medical Sciences , New Delhi , India.
authors.forename: Prasenjit
authors.initials: P
authors.lastname: Das
authors.affiliation: Department of Pathology , All India Institute of Medical Sciences , New Delhi , India.
authors.forename: Siddharth
authors.initials: S
authors.lastname: Dattagupta
authors.affiliation: Department of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
authors.forename: Veena
authors.initials: V
authors.lastname: Mishra
authors.affiliation: Department of Gastroenterology and Human Nutrition , All India Institute of Medical Sciences , New Delhi , India.
authors.forename: Sushil Kumar
authors.initials: SK
authors.lastname: Garg
keywords: 5-AMINOSALICYLIC ACID (5-ASA); MICROSCOPIC COLITIS; PROBIOTICS