Status:
UNKNOWN
Probiotic After Acute Colonic Diverticulitis
Lead Sponsor:
Erasmo Spaziani
Conditions:
Diverticulitis, Colonic
Therapy
Eligibility:
All Genders
18+ years
Brief Summary
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 epis...
Eligibility Criteria
Inclusion
- Symptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis;
- Symptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to .surgical colonic resection without stoma;
- Patients with diverticulosis;
- Asymptomatic patients three months after an episode of uncomplicated acute colonic diverticulitis;
- Asymptomatic patients six months after an episode of complicated acute colonic diverticulitis; submitted to surgical colonic resection without stoma.
Exclusion
- Ongoing acute diverticulitis at radiologic assessment
- Antibiotic therapy, both systemic and topic, and/or probiotics and/or mesalazine within four weeks before enrolment;
- Lactulose-lactitol use within four weeks before enrolment;
- Presence of chronic inflammatory bowel diseases;
- Presence of Segmental Colitis Associated with Diverticulitis (SCAD);
- Presence of ischemic colitis;
- Severe chronic liver (Child-Pugh C) and/or pancreatic and/or renal diseases;
- Patients with severe renal failure;
- Presence of suspected/actual pregnancy;
- Presence of recent/ongoing neoplasia, under oncological treatment within 6 months before enrolment;
- Presence of COVID-19 infection;
- Patients unable to give informed consent.
Key Trial Info
Start Date :
May 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT06040515
Start Date
May 1 2023
End Date
June 30 2024
Last Update
September 15 2023
Active Locations (12)
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1
UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Pugliese-Ciaccio
Catanzaro, Calabria, Italy, 88100
2
UOSVD di Endoscopia Digestiva, Ospedale "S. Maria Goretti"
Latina, Lazio, Italy, 04100
3
UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini"
Rome, Lazio, Italy, 00152
4
UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I"
Rome, Lazio, Italy, 00161