DIVERTICULAR DISEASE MedDRA version: 14.1 Level: HLGT Classification code 10013535 Term: Diverticular disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: PENTACOL 800
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Mesalazine
Concentration unit: mg milligram(s)
Concentration number: 800-
Product Name: NA
Product Code: NA
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria:  males and females aged >18 years;  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. Every investigator will recorded which treatment obtained remission (antibiotics, probiotics, both, etc)  patients who have given their free and informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria:  diverticular colitis;  active or recent peptic ulcer;  chronic renal insufficiency;  allergy to salicylates;  patients with intended or ascertained pregnancy, lactation  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 are 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  previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess the safety and the efficacy of mesalazine and/or Lactobacillus casei DG in maintaining remission of symptomatic uncomplicated diverticular disease of the colon;Secondary Objective: na;Primary end point(s): remission DIVERTICULAR DISEASE | — |
Countries
Italy
Outcome results
None listed