Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
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
Inclusion Criteria:

 -  diagnosis of diverticular disease diagnosed for the first time or established by
 previous colonoscopy

 -  symptomatic episode of uncomplicated diverticular disease no more than 4 weeks prior
 to study entry

 -  patients who have given their free and informed consent.

 Exclusion Criteria:

 -  acute diverticulitis (both complicated and uncomplicated)

 -  diverticular colitis

 -  active or recent peptic ulcer

 -  chronic renal insufficiency

 -  allergy to salicylates

 -  patients with intended or ascertained pregnancy, lactation

 -  women of childbearing age not using contraceptives

 -  lactulose-lactitol use in the two weeks before the enrolment and during the study

 -  presence of diverticulitis complications (fistulas, abscesses, and/or stenoses)

 -  use of probiotic preparations either prescribed or over-the counter within two weeks
 prior to study entry

 -  inability to give a valid informed consent or to properly follow the protocol

 -  patients with active malignancy of any type, or history of a malignancy (patients with
 a history of other malignancies that have been surgically removed and who have no
 evidence of recurrence for at least five years before study enrolment were also
 acceptable)

 -  recent history or suspicion of alcohol abuse or drug addiction

 -  any severe pathology that can interfere with the treatment or the clinical or
 instrumental tests of the trial

 -  use of NSAIDS for one week before and throughout the study period (only paracetamol
 was permitted).