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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Brandimarte, Hospital Cristo Re
ClinicalTrials.gov Identifier:
NCT01534754
First received: February 4, 2012
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Diverticular Disease of the Colon
 Drug: Mesalazine plus Lactobacillus casei
Drug: Mesalazine placebo plus Lactobacillus casei placebo
Drug: Mesalazine 800 mg
Drug: Lactobacillus casei
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Cristo Re:

Primary Outcome Measures:
  • Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of the treatments [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events

  • Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Concomitant diseases [ Time Frame: one year ] [ Designated as safety issue: No ]
    Influence of concomitant diseases on remission maintenance


Enrollment: 250
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534754

Locations
Italy
Hospital Bonomo
Andria, Bari, Italy, 70031
Hospital "Padre Pio"
Vasto, Chieti, Italy, 66054
Hospital "Humanitas"
Rozzano, Milano, Italy, 20089
Ospedale Civile Hospital
Popoli, Pescara, Italy, 65026
Hospital "S. Giuseppe"
Albano, Rome, Italy, 00041
Hospital "G.B. Grassi"
Ostia, Rome, Italy, 00122
Hospital "P. Colombo"
Velletri, Rome, Italy, 00049
Hospital Policlinico
Bari, Italy, 70124
Hospital "Pulgiese-Ciaccio"
Catanzaro, Italy, 88100
Hospital "Ospedali Riuniti"
Foggia, Italy, 71122
Hospital "S. Maria Goretti"
Latina, Italy, 04100
Hopsitla Policlinico
Reggio Calabria, Italy, 89100
Hospital "Cristo Re"
Rome, Italy, 00167
Hospital "S. Eugenio"
Rome, Italy, 00144
Sponsors and Collaborators
Hospital Cristo Re
Investigators
Principal Investigator: Giovanni Brandimarte, M.D. Head of Gastroenterology, Hospital "Cristo Re" - Rome
  More Information

No publications provided

Responsible Party: Giovanni Brandimarte, MD; PhD, Hospital Cristo Re
ClinicalTrials.gov Identifier: NCT01534754     History of Changes
Other Study ID Numbers: 2006-00064322-25
Study First Received: February 4, 2012
Last Updated: February 14, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Diverticulum
Diverticulosis, Colonic
Pathological Conditions, Anatomical
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013