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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
Active Mesalazine 800 mg, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.
Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for oe year.
Active mesalazine 800 mg, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for one year.
Mesalazine 800 mg placebo, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.
Hospital Bonomo
Andria, Bari, Italy
Hospital Policlinico
Bari, Bari, Italy
Hospital "Pulgiese-Ciaccio"
Catanzaro, Catanzaro, Italy
Hospital "Padre Pio"
Vasto, Chieti, Italy
Hospital "Ospedali Riuniti"
Foggia, Foggia, Italy
Hospital "S. Maria Goretti"
Latina, Latina, Italy
Hospital "Humanitas"
Rozzano, Milano, Italy
Ospedale Civile Hospital
Popoli, Pescara, Italy
Hopsitla Policlinico
Reggio Calabria, Reggio Calabria, Italy
Hospital "S. Giuseppe"
Albano Laziale, Rome, Italy
...and 4 more locations
Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon
Time frame: one year
Safety of the treatments
Number of participants with adverse events
Time frame: one year
Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon
Time frame: one year
Concomitant diseases
Influence of concomitant diseases on remission maintenance
Time frame: one year
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