Diverticular Disease of the Colon
Conditions
Brief 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
Interventions
DRUGMesalazine plus Lactobacillus casei
Active Mesalazine 800 mg, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.
DRUGMesalazine placebo plus Lactobacillus casei placebo
Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for oe year.
DRUGMesalazine 800 mg
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.
Sponsors
Hospital Cristo Re
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon | one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the treatments | one year | Number of participants with adverse events |
| Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon | one year | — |
| Concomitant diseases | one year | Influence of concomitant diseases on remission maintenance |
Countries
Italy
Outcome results
None listed