Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
Summary
This is a multi-centre, randomised, double blind, double-dummy, parallel groups,
placebo-controlled trial was conducted in a population of patients suffering from symptomatic
uncomplicated diverticular disease in order to investigate which is the best treatment in
preventing relapses of the disease.
Patients were randomly divided in double-blind fashion in one of the following groups:
Group A. Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei
placebo, 1 sachet/day for 10 days/month;
Group B. Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800
placebo, 2 tablets/day for 10 days/month;
Group C. Active mesalazine 800 ng, 2 tablets/day plus Active Lactobacillus casei, 1
sachet/day for 10 days/month;
Group D. Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1
sachet/day for 10 days/month.
The main objective was to assess the safety and the efficacy of mesalazine and/or
Lactobacillus casei in maintaining remission of symptomatic uncomplicated diverticular
disease