Please select the eligibility criteria that correspond to the clinical trial below.
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
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


Options:
A: Inclusion Criteria:

* adults with CT sign of acute colonic uncomplicated diverticulitis
* elevated CRP and LPK
* Temp.38c or more

Exclusion Criteria:

* patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air
* pregnancy
* immunological incompetence and immunosuppressive therapy
B: Inclusion Criteria:

* A clinical diagnosis of acute diverticulitis
* Female patients must be postmenopausal (at least 1 year without spontaneous menses) or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception (e.g., abstinence; oral, intramuscular, or implanted hormonal contraception \[at least 3 months prior to enrollment\]; 2-barrier methods \[e.g., condom, diaphragm, or spermicide\]; intrauterine device or verbal report of partner with history of non-reversed vasectomy)
* Willing and able to participate in the study and provide a signed informed consent

Exclusion Criteria:

* Presence of diverticular complications (e.g., fistula, abscess, obstruction, stenosis);
* Active or recent history (within 6 months) of a peptic ulcer;
* Prior history of irritable bowel syndrome (IBS), as determined by the Investigator;
* History of major abdominal surgery (as determined by the Investigator);
* History of GI surgery within 3 months of diagnosis of acute diverticulitis;
* History of immunocompromising disease, human immunodeficiency virus (HIV) infection, or acquired immunodeficiency syndrome (AIDS);
* If female patient, active or recent history of endometriosis or dysmenorrhea;
* Received a dose of a product that contains, or is metabolized to, mesalamine by any route within 4 weeks before the screening visit;
C: Inclusion Criteria:

* age ≥ 18 years
* both males and females patients
* positive history of acute diverticulitis flare during the last year. The patients will be recruited only after the complete clinical remission of diverticulitis flare.
* patients who have given their free and informed consent

Exclusion Criteria:

* complicated diverticulitis(fistulas, stenosis, abscesses and/or bleeding)
* ascertained hypersensitivity to the salicylates
* any severe pathology that can interfere with the treatment or the clinical or instrumental test of the trial
* clinically significant renal or hepatic impairment
* esophageal, gastric or duodenal ulcer within 30 days prior to randomisation
* patients with active malignancy of any type, or history of a malignancy (patients with a history of malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrollment are also acceptable)
* treatment with any investigational drug within the previous 30 days
* treatment with lactulose or with any compound that lowering the colonic pH can prevent the release of the active moiety from the tablets
* recent history or suspicion of alcohol abuse or drug addiction
* patients who become unable to conform to protocol
* patients with ascertained pregnancy
* previous participation in this study
D: 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).

Answer: D