Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
145 participants
OBSERVATIONAL
2023-05-01
2024-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Symptomatic patients after acute diverticulitis
Patients aged ≥18 with persistent symptoms at least three months after a radiologic and/or endoscopic documented acute diverticulitis or after six months of surgery for complicated acute diverticulitis.
Therapy with Escherichia coli Nissle 1917 (EcN®) will be prescribed for a global duration of six months with the following assumption schedule: 2 capsules b.i.d. during 4 weeks, followed by 1 capsule o.i.d during 20 days each month for 5 months.
Probiotic Formula
Capsule with 25 billion live strains of Escherichia coli Nissle 1917
Diverticulosis
Patients with asymptomatic diverticulosis. No therapy will be administered. Microbiota assessment will be performed.
No interventions assigned to this group
Asymptomatic patients after acute uncomplicated diverticulitis
Asymptomatic patients assessed three months after an episode of acute uncomplicated diverticulitis. No therapy will be administered. Microbiota assessment will be performed.
No interventions assigned to this group
Asymptomatic patients after acute complicated diverticulitis
Asymptomatic patients assessed six months after an episode of acute complicated diverticulitis submitted to surgery with resection and without stoma . No therapy will be administered. Microbiota assessment will be performed.
No interventions assigned to this group
Interventions
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Probiotic Formula
Capsule with 25 billion live strains of Escherichia coli Nissle 1917
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Erasmo Spaziani
OTHER
Responsible Party
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Erasmo Spaziani
MD, PhD
Principal Investigators
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Walter Elisei, MD
Role: PRINCIPAL_INVESTIGATOR
• UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma
Locations
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UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Pugliese-Ciaccio
Catanzaro, Calabria, Italy
UOSVD di Endoscopia Digestiva, Ospedale "S. Maria Goretti"
Latina, Lazio, Italy
UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini"
Rome, Lazio, Italy
UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I"
Rome, Lazio, Italy
UOC di Medicina Interna e Gastroenterologia, Ospedale "Cristo Re"
Rome, Lazio, Italy
UOC Chirurgia Generale, Ospedale "P. Colombo"
Velletri, Lazio, Italy
UOC di Gastroenterologia, Ospedale "Belcolle",
Viterbo, Lazio, Italy
• UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale Universitario "San Raffaele"
Milan, Lombardy, Italy
UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova
Padova, Lombardy, Italy
UOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto"
Piacenza, Lombardy, Italy
UOC di Gastroenterologia, Ospedale "S. Salvatore",
Pesaro, The Marches, Italy
Gastroenterology Service , ASL BAT,
Andria, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Kvasnovsky CL, Adams K, Papagrigoriadis S. Diverticular disease as a chronic gastrointestinal condition: experience from a specialist clinic. Eur J Gastroenterol Hepatol. 2015 Apr;27(4):442-8. doi: 10.1097/MEG.0000000000000304.
Mj O, Turner GA, A S, Frizelle FA, R P. Distinct changes in the colonic microbiome associated with acute diverticulitis. Colorectal Dis. 2022 Dec;24(12):1591-1601. doi: 10.1111/codi.16271. Epub 2022 Aug 11.
Tursi A, Papa V, Lopetuso LR, Settanni CR, Gasbarrini A, Papa A. Microbiota Composition in Diverticular Disease: Implications for Therapy. Int J Mol Sci. 2022 Nov 26;23(23):14799. doi: 10.3390/ijms232314799.
Teng G, Liu Z, Liu Y, Wu T, Dai Y, Wang H, Wang W. Probiotic Escherichia coli Nissle 1917 Expressing Elafin Protects Against Inflammation and Restores the Gut Microbiota. Front Microbiol. 2022 May 6;13:819336. doi: 10.3389/fmicb.2022.819336. eCollection 2022.
Lahat A, Fidder HH, Ben-Horin S. Development and validation of a diverticular clinical score for symptomatic uncomplicated diverticular disease after acute diverticulitis in a prospective patient cohort. Therap Adv Gastroenterol. 2020 May 8;13:1756284820913210. doi: 10.1177/1756284820913210. eCollection 2020.
Other Identifiers
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EcN2023
Identifier Type: -
Identifier Source: org_study_id
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