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

NCT ID: NCT01534754

Last Updated: 2012-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

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

Conditions

Diverticular Disease of the Colon

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Mesalazine

Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month.

Group Type: ACTIVE_COMPARATOR

Mesalazine 800 mg

Intervention Type: DRUG

Active mesalazine 800 mg, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for one year.

Lactobacillus casei

Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 mg placebo, 2 tablets/day for 10 days/month.

Group Type: ACTIVE_COMPARATOR

Lactobacillus casei

Intervention Type: DRUG

Mesalazine 800 mg placebo, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.

Mesalazine plus Lactobacillus casei

Active mesalazine 800 mg, 2 tablets/day plus active Lactobacillus casi, 1 sachet/day for 10 days/month.

Group Type: ACTIVE_COMPARATOR

Mesalazine plus Lactobacillus casei

Intervention Type: DRUG

Active Mesalazine 800 mg, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.

Placebo

Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month.

Group Type: PLACEBO_COMPARATOR

Mesalazine placebo plus Lactobacillus casei placebo

Intervention Type: DRUG

Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for oe year.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Lactobacillus casei

Mesalazine 800 mg placebo, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Cristo Re

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Brandimarte

MD; PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Brandimarte, M.D.

Role: PRINCIPAL_INVESTIGATOR

Head of Gastroenterology, Hospital "Cristo Re" - Rome

Locations

Hospital Bonomo

Andria, Bari, Italy

Hospital Policlinico

Bari, Bari, Italy

Hospital "Pulgiese-Ciaccio"

Catanzaro, Catanzaro, Italy

Hospital "Padre Pio"

Vasto, Chieti, Italy

Hospital "Ospedali Riuniti"

Foggia, Foggia, Italy

Hospital "S. Maria Goretti"

Latina, Latina, Italy

Hospital "Humanitas"

Rozzano, Milano, Italy

Ospedale Civile Hospital

Popoli, Pescara, Italy

Hopsitla Policlinico

Reggio Calabria, Reggio Calabria, Italy

Hospital "S. Giuseppe"

Albano Laziale, Rome, Italy

Hospital "G.B. Grassi"

Ostia Antica, Rome, Italy

Hospital "S. Eugenio"

Rome, Rome, Italy

Hospital "P. Colombo"

Velletri, Rome, Italy

Hospital "Cristo Re"

Rome, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 23957734 (View on PubMed)

Other Identifiers

2006-00064322-25

Identifier Type: -

Identifier Source: org_study_id