Diverticular Disease of the Colon Clinical Trial
Official title:
Mesalazine and/or Lactobacillus Casei in Maintaining Remission of Symptomatic Uncomplicated Diverticular Disease of the Colon: a Double-blind, Double-dummy, Placebo-controlled Study
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
| Status | Completed |
| Enrollment | 250 |
| Est. completion date | December 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Hospital "S. Giuseppe" | Albano | Rome |
| Italy | Hospital Bonomo | Andria | Bari |
| Italy | Hospital Policlinico | Bari | |
| Italy | Hospital "Pulgiese-Ciaccio" | Catanzaro | |
| Italy | Hospital "Ospedali Riuniti" | Foggia | |
| Italy | Hospital "S. Maria Goretti" | Latina | |
| Italy | Hospital "G.B. Grassi" | Ostia | Rome |
| Italy | Ospedale Civile Hospital | Popoli | Pescara |
| Italy | Hopsitla Policlinico | Reggio Calabria | |
| Italy | Hospital "Cristo Re" | Rome | |
| Italy | Hospital "S. Eugenio" | Rome | |
| Italy | Hospital "Humanitas" | Rozzano | Milano |
| Italy | Hospital "Padre Pio" | Vasto | Chieti |
| Italy | Hospital "P. Colombo" | Velletri | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Cristo Re |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon | one year | No | |
| Secondary | Safety of the treatments | Number of participants with adverse events | one year | Yes |
| Secondary | Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon | one year | No | |
| Secondary | Concomitant diseases | Influence of concomitant diseases on remission maintenance | one year | No |