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

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

Timeline

Start

2009-01

Primary completion

2011-10

Completion

2011-12

Publications

• Tursi A, Picchio M, Elisei W, Brandimarte G, Di Mario F, Danese S, Papa A. Lactobacillus Paracasei CNCM I 1572 is Better than Placebo in Preventing Acute Diverticulitis Occurrence (Revised Manuscript 661a120f-b910-4133-ab7e-4bd3e1713c96). Probiotics Antimicrob Proteins. 2026 Apr;18(3):4738-4745. doi: 10.1007/s12602-025-10812-y. Epub 2025 Oct 17.
• Tursi A, Brandimarte G, Elisei W, Picchio M, Forti G, Pianese G, Rodino S, D'Amico T, Sacca N, Portincasa P, Capezzuto E, Lattanzio R, Spadaccini A, Fiorella S, Polimeni F, Polimeni N, Stoppino V, Stoppino G, Giorgetti GM, Aiello F, Danese S. Randomised clinical trial: mesalazine and/or probiotics in maintaining remission of symptomatic uncomplicated diverticular disease--a double-blind, randomised, placebo-controlled study. Aliment Pharmacol Ther. 2013 Oct;38(7):741-51. doi: 10.1111/apt.12463. Epub 2013 Aug 19.

Drugs

Indications