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Completed

NCT Number: NCT01534754

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

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

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Key information

Conditions

Diverticular Disease of the Colon

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Bonomo, Andria, Bari, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mesalazine plus Lactobacillus casei

Drug

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

Mesalazine placebo plus Lactobacillus casei placebo

Drug

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

Mesalazine 800 mg

Drug

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

Lactobacillus casei

Drug

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

Primary outcomes

  1. Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon

    Time frame: one year

Secondary outcomes

  1. Safety of the treatments

    Time frame: one year

    Number of participants with adverse events

  2. Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon

    Time frame: one year

  3. Concomitant diseases

    Time frame: one year

    Influence of concomitant diseases on remission maintenance

Sponsors and collaborators

Lead sponsor

Hospital Cristo Re

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 17, 2012
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.