Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
1 other identifier
interventional
250
1 country
14
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2009
Typical duration for phase_4
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 4, 2012
CompletedFirst Posted
Study publicly available on registry
February 17, 2012
CompletedFebruary 17, 2012
February 1, 2012
2.7 years
February 4, 2012
February 14, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon
one year
Secondary Outcomes (3)
Safety of the treatments
one year
Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon
one year
Concomitant diseases
one year
Study Arms (4)
Mesalazine
ACTIVE COMPARATORActive mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month.
Lactobacillus casei
ACTIVE COMPARATORActive Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 mg placebo, 2 tablets/day for 10 days/month.
Mesalazine plus Lactobacillus casei
ACTIVE COMPARATORActive mesalazine 800 mg, 2 tablets/day plus active Lactobacillus casi, 1 sachet/day for 10 days/month.
Placebo
PLACEBO COMPARATORMesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month.
Interventions
Active Mesalazine 800 mg, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.
Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for oe year.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Hospital Bonomo
Andria, Bari, 70031, Italy
Hospital Policlinico
Bari, Bari, 70124, Italy
Hospital "Pulgiese-Ciaccio"
Catanzaro, Catanzaro, 88100, Italy
Hospital "Padre Pio"
Vasto, Chieti, 66054, Italy
Hospital "Ospedali Riuniti"
Foggia, Foggia, 71122, Italy
Hospital "S. Maria Goretti"
Latina, Latina, 04100, Italy
Hospital "Humanitas"
Rozzano, Milano, 20089, Italy
Ospedale Civile Hospital
Popoli, Pescara, 65026, Italy
Hopsitla Policlinico
Reggio Calabria, Reggio Calabria, 89100, Italy
Hospital "S. Giuseppe"
Albano Laziale, Rome, 00041, Italy
Hospital "G.B. Grassi"
Ostia Antica, Rome, 00122, Italy
Hospital "S. Eugenio"
Rome, Rome, 00144, Italy
Hospital "P. Colombo"
Velletri, Rome, 00049, Italy
Hospital "Cristo Re"
Rome, 00167, Italy
Related Publications (1)
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.
PMID: 23957734DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giovanni Brandimarte, M.D.
Head of Gastroenterology, Hospital "Cristo Re" - Rome
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD; PhD
Study Record Dates
First Submitted
February 4, 2012
First Posted
February 17, 2012
Study Start
January 1, 2009
Primary Completion
October 1, 2011
Study Completion
December 1, 2011
Last Updated
February 17, 2012
Record last verified: 2012-02