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

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

Study Overview

• Status: Completed
• Conditions: Diverticular Disease of the Colon
• Intervention / Treatment: Drug: Mesalazine 800 mg; Drug: Lactobacillus casei; Drug: Mesalazine plus Lactobacillus casei; Drug: Mesalazine placebo plus Lactobacillus casei placebo

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • Hospital Policlinico
  • Catanzaro, Italy, 88100
    • Hospital "Pulgiese-Ciaccio"
  • Foggia, Italy, 71122
    • Hospital "Ospedali Riuniti"
  • Latina, Italy, 04100
    • Hospital "S. Maria Goretti"
  • Reggio Calabria, Italy, 89100
    • Hopsitla Policlinico
  • Rome, Italy, 00144
    • Hospital "S. Eugenio"
  • Rome, Italy, 00167
    • Hospital "Cristo Re"
  • Bari
    • Andria, Bari, Italy, 70031
      • Hospital Bonomo
  • Chieti
    • Vasto, Chieti, Italy, 66054
      • Hospital "Padre Pio"
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Hospital "Humanitas"
  • Pescara
    • Popoli, Pescara, Italy, 65026
      • Ospedale Civile Hospital
  • Rome
    • Albano, Rome, Italy, 00041
      • Hospital "S. Giuseppe"
    • Ostia, Rome, Italy, 00122
      • Hospital "G.B. Grassi"
    • Velletri, Rome, Italy, 00049
      • Hospital "P. Colombo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Hospital Cristo Re
• Investigators: Principal Investigator: Giovanni Brandimarte, M.D., Head of Gastroenterology, Hospital "Cristo Re" - Rome

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 4, 2012
• First Submitted That Met QC Criteria: February 14, 2012
• First Posted (Estimate): February 17, 2012

Study Record Updates

• Last Update Posted (Estimate): February 17, 2012
• Last Update Submitted That Met QC Criteria: February 14, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Pathological Conditions, Anatomical; Diverticulum; Diverticular Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: 2006-00064322-25