The goal of this observational study is to assess the efficacy and safety of the probiotic Escherichia coli Nissle 1917 (EcN®, Ca.Di.Group S.p.A) in the treatment of symptomatic patients after an episode of both complicated and uncomplicated acute colonic diverticulitis. The main question it aims to answer are: * Is the studied probiotic able to significantly reduce symptoms, assessed by means of a validated and dedicated score? * Is there any difference in microbiota among the study group at baseline and a selected cohort of patients subdivided in subjects with diverticulosis and asymptomatic subjects after an episode of acute uncomplicated diverticulitis or an episode of complicated diverticulitis submitted to surgery with colonic resection without stoma? * Is there any difference in microbiota in the study group at baseline and after 3 and 6 months of treatment with the probiotic? * Is there any correlation between microbiota modification and symptoms during follow-up? * Is there any impact on fecal calprotectin values before and during probiotic therapy? * Is there any modification of evacuation before and during follow-up? * Is probiotic able to prevent recurrent episodes of acute diverticulitis during follow-up? * The safety of the probiotic will be assessed during the follow-up. The study group will be assessed at baseline and during follow-up with a dedicated clinical score and Bristol stool scale. Microbiota and fecal calprotectin values will be also assessed at baseline and during follow-up. Microbiota at baseline will be also evaluated for comparison in the three selected groups with diverticulosis and both asymptomatic and symptomatic after an episode of acute diverticulitis.
Study Type
OBSERVATIONAL
Enrollment
145
Capsule with 25 billion live strains of Escherichia coli Nissle 1917
UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Pugliese-Ciaccio
Catanzaro, Calabria, Italy
RECRUITINGUOSVD di Endoscopia Digestiva, Ospedale "S. Maria Goretti"
Latina, Lazio, Italy
RECRUITINGUOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini"
Rome, Lazio, Italy
RECRUITINGUOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I"
Rome, Lazio, Italy
RECRUITINGUOC di Medicina Interna e Gastroenterologia, Ospedale "Cristo Re"
Rome, Lazio, Italy
RECRUITINGUOC Chirurgia Generale, Ospedale "P. Colombo"
Velletri, Lazio, Italy
RECRUITINGUOC di Gastroenterologia, Ospedale "Belcolle",
Viterbo, Lazio, Italy
RECRUITING• UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale Universitario "San Raffaele"
Milan, Lombardy, Italy
RECRUITINGUOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova
Padova, Lombardy, Italy
RECRUITINGUOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto"
Piacenza, Lombardy, Italy
RECRUITING...and 2 more locations
Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917
Median symptomatic score assessed at baseline and during follow-up
Time frame: Six-months follow-up
Microbiota qualitative composition
Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection.
Time frame: Baseline
Microbiota qualitative composition modification
Composition of microbiota will be assessed in symptomatic study groups with a dedicated kit for collection.
Time frame: Baseline and during 6-month follow-up.
Microbiota qualitative composition and median symptomatic score correlation
Correlation between the median symptomatic score and qualitative composition of microbiota modification after therapy.
Time frame: Baseline and during 6-month follow-up.
Concentration of fecal calprotectin
Assessment of fecal calprotectin concentration in the symptomatic study group.
Time frame: Baseline and during 6-month follow-up.
Bristol stool scale modification
Assessment of median Bristol stool scale in the symptomatic study group.
Time frame: Baseline and during 6-month follow-up.
Prevention of recurrent acute diverticulitis
Number off patients with recurrent acute diverticulitis.
Time frame: Six-month follow-up.
Safety
Number of patients with adverse events.
Time frame: Six-month follow-up.
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