Clinical trial NCT01534754: Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diverticular Disease of the Colon
Lead sponsor: Hospital Cristo Re
Sponsor class: OTHER
First posted: 2012-02-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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).

Primary outcomes:
measure: Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon
timeFrame: one year
Secondary outcomes:
measure: Safety of the treatments
timeFrame: one year
measure: Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon
timeFrame: one year
measure: Concomitant diseases
timeFrame: one year
Other outcomes:
Locations:
city: Andria
country: Italy
facility: Hospital Bonomo
state: Bari
city: Vasto
country: Italy
facility: Hospital "Padre Pio"
state: Chieti
city: Rozzano
country: Italy
facility: Hospital "Humanitas"
state: Milano
city: Popoli
country: Italy
facility: Ospedale Civile Hospital
state: Pescara
city: Albano
country: Italy
facility: Hospital "S. Giuseppe"
state: Rome
city: Ostia
country: Italy
facility: Hospital "G.B. Grassi"
state: Rome
city: Velletri
country: Italy
facility: Hospital "P. Colombo"
state: Rome
city: Bari
country: Italy
facility: Hospital Policlinico
city: Catanzaro
country: Italy
facility: Hospital "Pulgiese-Ciaccio"
city: Foggia
country: Italy
facility: Hospital "Ospedali Riuniti"
city: Latina
country: Italy
facility: Hospital "S. Maria Goretti"
city: Reggio Calabria
country: Italy
facility: Hopsitla Policlinico
city: Rome
country: Italy
facility: Hospital "S. Eugenio"
city: Rome
country: Italy
facility: Hospital "Cristo Re"
Study officials:
affiliation: Head of Gastroenterology, Hospital "Cristo Re" - Rome
name: Giovanni Brandimarte, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.