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

Study Overview
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Brief Summary
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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

Official Title
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Mesalazine and/or Lactobacillus Casei in Maintaining Remission of Symptomatic Uncomplicated Diverticular Disease of the Colon: a Double-blind, Double-dummy, Placebo-controlled Study

Conditions
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Diverticular Disease of the Colon

Intervention / Treatment
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* Drug: Mesalazine plus Lactobacillus casei
* Drug: Mesalazine placebo plus Lactobacillus casei placebo
* Drug: Mesalazine 800 mg
* Drug: Lactobacillus casei


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesalazine<br>Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month. | Drug: Mesalazine 800 mg<br>* Active mesalazine 800 mg, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for one year.<br>|
| Active Comparator: Lactobacillus casei<br>Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 mg placebo, 2 tablets/day for 10 days/month. | Drug: Lactobacillus casei<br>* Mesalazine 800 mg placebo, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.<br>|
| Active Comparator: Mesalazine plus Lactobacillus casei<br>Active mesalazine 800 mg, 2 tablets/day plus active Lactobacillus casi, 1 sachet/day for 10 days/month. | Drug: Mesalazine plus Lactobacillus casei<br>* Active Mesalazine 800 mg, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.<br>|
| Placebo Comparator: Placebo<br>Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month. | Drug: Mesalazine placebo plus Lactobacillus casei placebo<br>* Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for oe year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the treatments | Number of participants with adverse events | one year | 
| Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon |  | one year | 
| Concomitant diseases | Influence of concomitant diseases on remission maintenance | one year |