Diverticular Disease of the Colon Clinical Trial
Official title:
Mesalazine and/or Lactobacillus Casei in Maintaining Remission of Symptomatic Uncomplicated Diverticular Disease of the Colon: a Double-blind, Double-dummy, Placebo-controlled Study
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
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment