Back to resultsMesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
Primary Purpose
Diverticular Disease of the Colon
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Mesalazine plus Lactobacillus casei
Mesalazine placebo plus Lactobacillus casei placebo
Mesalazine 800 mg
Lactobacillus casei
Sponsored by
About this trial
This is an interventional treatment trial for Diverticular Disease of the Colon
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).
Sites / Locations
- Hospital Bonomo
- Hospital "Padre Pio"
- Hospital "Humanitas"
- Ospedale Civile Hospital
- Hospital "S. Giuseppe"
- Hospital "G.B. Grassi"
- Hospital "P. Colombo"
- Hospital Policlinico
- Hospital "Pulgiese-Ciaccio"
- Hospital "Ospedali Riuniti"
- Hospital "S. Maria Goretti"
- Hopsitla Policlinico
- Hospital "S. Eugenio"
- Hospital "Cristo Re"
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Mesalazine
Lactobacillus casei
Mesalazine plus Lactobacillus casei
Placebo
Arm Description
Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month.
Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 mg placebo, 2 tablets/day for 10 days/month.
Active mesalazine 800 mg, 2 tablets/day plus active Lactobacillus casi, 1 sachet/day for 10 days/month.
Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month.
Outcomes
Primary Outcome Measures
Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon
Secondary Outcome Measures
Safety of the treatments
Number of participants with adverse events
Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon
Concomitant diseases
Influence of concomitant diseases on remission maintenance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01534754
Brief Title
Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Cristo Re
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticular Disease of the Colon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mesalazine
Arm Type
Active Comparator
Arm Description
Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month.
Arm Title
Lactobacillus casei
Arm Type
Active Comparator
Arm Description
Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 mg placebo, 2 tablets/day for 10 days/month.
Arm Title
Mesalazine plus Lactobacillus casei
Arm Type
Active Comparator
Arm Description
Active mesalazine 800 mg, 2 tablets/day plus active Lactobacillus casi, 1 sachet/day for 10 days/month.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month.
Intervention Type
Drug
Intervention Name(s)
Mesalazine plus Lactobacillus casei
Intervention Description
Active Mesalazine 800 mg, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.
Intervention Type
Drug
Intervention Name(s)
Mesalazine placebo plus Lactobacillus casei placebo
Intervention Description
Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for oe year.
Intervention Type
Drug
Intervention Name(s)
Mesalazine 800 mg
Intervention Description
Active mesalazine 800 mg, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for one year.
Intervention Type
Drug
Intervention Name(s)
Lactobacillus casei
Intervention Description
Mesalazine 800 mg placebo, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.
Primary Outcome Measure Information:
Title
Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon
Time Frame
one year
Secondary Outcome Measure Information:
Title
Safety of the treatments
Description
Number of participants with adverse events
Time Frame
one year
Title
Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon
Time Frame
one year
Title
Concomitant diseases
Description
Influence of concomitant diseases on remission maintenance
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Brandimarte, M.D.
Organizational Affiliation
Head of Gastroenterology, Hospital "Cristo Re" - Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Bonomo
City
Andria
State/Province
Bari
ZIP/Postal Code
70031
Country
Italy
Facility Name
Hospital "Padre Pio"
City
Vasto
State/Province
Chieti
ZIP/Postal Code
66054
Country
Italy
Facility Name
Hospital "Humanitas"
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale Civile Hospital
City
Popoli
State/Province
Pescara
ZIP/Postal Code
65026
Country
Italy
Facility Name
Hospital "S. Giuseppe"
City
Albano
State/Province
Rome
ZIP/Postal Code
00041
Country
Italy
Facility Name
Hospital "G.B. Grassi"
City
Ostia
State/Province
Rome
ZIP/Postal Code
00122
Country
Italy
Facility Name
Hospital "P. Colombo"
City
Velletri
State/Province
Rome
ZIP/Postal Code
00049
Country
Italy
Facility Name
Hospital Policlinico
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Hospital "Pulgiese-Ciaccio"
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Hospital "Ospedali Riuniti"
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Facility Name
Hospital "S. Maria Goretti"
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Hopsitla Policlinico
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Hospital "S. Eugenio"
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Hospital "Cristo Re"
City
Rome
ZIP/Postal Code
00167
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23957734
Citation
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.
Results Reference
derived
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Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
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