Diverticular Disease of the ColonPhase 4NCT01534754
Mesalazine and/or Lactobacillus Casei in the Diverticular Disease of the Colon
A Phase 4 study testing Mesalazine plus Lactobacillus casei, Mesalazine 800 mg and Lactobacillus casei in people with Diverticular Disease of the Colon, run by Hospital Cristo Re at 14 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease of the Colon
- What is being tested?
- Mesalazine plus Lactobacillus casei, Mesalazine 800 mg and Lactobacillus casei
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 14 sitesItaly
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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).
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Hospital "S. Giuseppe"
Albano Laziale, Rome, 00041
Hospital Bonomo
Andria, Bari, 70031
Hospital Policlinico
Bari, Bari, 70124
Hospital "Pulgiese-Ciaccio"
Catanzaro, Catanzaro, 88100
Hospital "Ospedali Riuniti"
Foggia, Foggia, 71122
Hospital "S. Maria Goretti"
Latina, Latina, 04100
Hospital "G.B. Grassi"
Ostia Antica, Rome, 00122
Ospedale Civile Hospital
Popoli, Pescara, 65026
Hopsitla Policlinico
Reggio Calabria, Reggio Calabria, 89100
Hospital "S. Eugenio"
Rome, Rome, 00144
Hospital "Cristo Re"
Rome, 00167
Hospital "Humanitas"
Rozzano, Milano, 20089
Hospital "Padre Pio"
Vasto, Chieti, 66054
Hospital "P. Colombo"
Velletri, Rome, 00049
About this study
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
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:
Read more
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
- Being tested
- Mesalazine plus Lactobacillus casei, Mesalazine placebo plus Lactobacillus casei placebo, Mesalazine 800 mg, Lactobacillus casei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesalazine plus Lactobacillus caseiDrug
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 placeboDrug
Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for oe year.
Mesalazine 800 mgDrug
Active mesalazine 800 mg, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for one year.
Lactobacillus caseiDrug
Mesalazine 800 mg placebo, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine | Active comparator | Active mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month. Receives: Drug: Mesalazine 800 mg |
| Lactobacillus casei | Active comparator | Active Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 mg placebo, 2 tablets/day for 10 days/month. Receives: Drug: Lactobacillus casei |
| Mesalazine plus Lactobacillus casei | Active comparator | Active mesalazine 800 mg, 2 tablets/day plus active Lactobacillus casi, 1 sachet/day for 10 days/month. Receives: Drug: Mesalazine plus Lactobacillus casei |
| Placebo | Placebo comparator | Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month. Receives: Drug: Mesalazine placebo plus Lactobacillus casei placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon
Measured: one year
Secondary outcomes (3)
Safety of the treatments
Number of participants with adverse events
Measured: one year
Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon
Measured: one year
Concomitant diseases
Influence of concomitant diseases on remission maintenance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startJan 2009
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diverticular Disease of the ColonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Cristo Re
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Brandimarte, Hospital Cristo Re
- Investigators
- Giovanni Brandimarte, M.D., Principal investigator, Head of Gastroenterology, Hospital "Cristo Re" - Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534754
- Sponsor's protocol ID
- 2006-00064322-25
- Status last verified
- Feb 2012
- First submitted
- 4 Feb 2012
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Tursi A, Picchio M, Elisei W, Brandimarte G, Di Mario F, Danese S, Papa A. Lactobacillus Paracasei CNCM I 1572 is Better than Placebo in Preventing Acute Diverticulitis Occurrence (Revised Manuscript 661a120f-b910-4133-ab7e-4bd3e1713c96). Probiotics Antimicrob Proteins. 2026 Apr;18(3):4738-4745. doi: 10.1007/s12602-025-10812-y. Epub 2025 Oct 17.
PubMed 41105168Tursi 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.
PubMed 23957734
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01534754
- Acronym / sponsor ID
- 2006-00064322-25
- Conditions
- Diverticular Disease of the Colon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospital Cristo ReUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mesalazine | Active comparator | Drug: Mesalazine 800 mgActive mesalazine 800 mg, 2 tablets/day for 10 days/month plus Lactobacillus casei placebo, 1 sachet/day for 10 days/month. |
| Lactobacillus casei | Active comparator | Drug: Lactobacillus caseiActive Lactobacillus casei, 1 sachet/day for 10 days/month plus mesalazine 800 mg placebo, 2 tablets/day for 10 days/month. |
| Mesalazine plus Lactobacillus casei | Active comparator | Drug: Mesalazine plus Lactobacillus caseiActive mesalazine 800 mg, 2 tablets/day plus active Lactobacillus casi, 1 sachet/day for 10 days/month. |
| Placebo | Placebo comparator | Drug: Mesalazine placebo plus Lactobacillus casei placeboMesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- acute diverticulitis (both complicated and uncomplicated)
- diverticular colitis
- active or recent peptic ulcer
- chronic renal insufficiency
- allergy to salicylates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesalazine plus Lactobacillus caseiActive Mesalazine 800 mg, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year. | Drug | Mesalazine plus Lactobacillus casei |
| Mesalazine placebo plus Lactobacillus casei placeboMesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for oe year. | Drug | Placebo |
| Mesalazine 800 mgActive mesalazine 800 mg, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for one year. | Drug | Mesalazine |
| Lactobacillus caseiMesalazine 800 mg placebo, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year. | Drug | Lactobacillus casei |
Primary outcome
Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon
Time frame: one year
3 secondary outcomes
Safety of the treatments
Time frame: one year
Influence of severity of diverticulosis on number of patients maintaining remission of symptomatic diverticular disease of the colon
Time frame: one year
Concomitant diseases
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- Derived from this study: PubMed 41105168Tursi A, Picchio M, Elisei W, Brandimarte G, Di Mario F, Danese S, Papa A. Lactobacillus Paracasei CNCM I 1572 is Better than Placebo in Preventing Acute Diverticulitis Occurrence (Revised Manuscript 661a120f-b910-4133-ab7e-4bd3e1713c96). Probiotics Antimicrob Proteins. 2026 Apr;18(3):4738-4745. doi: 10.1007/s12602-025-10812-y. Epub 2025 Oct 17.
- Derived from this study: PubMed 23957734Tursi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Brandimarte, M.D. principal investigator
Head of Gastroenterology, Hospital "Cristo Re" - Rome
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mesalazine plus Lactobacillus casei, Mesalazine 800 mg and Lactobacillus casei in people with Diverticular Disease of the Colon, run by Hospital Cristo Re at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients maintaining remission of symptomatic uncomplicated diverticular disease of the colon (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01534754, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.