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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Diverticulosis | Patients with asymptomatic diverticulosis. No therapy will be administered. Microbiota assessment will be performed. | ||
| 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. | ||
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Formula | Drug | Capsule with 25 billion live strains of Escherichia coli Nissle 1917 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917 | Median symptomatic score assessed at baseline and during follow-up | Six-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiota qualitative composition | Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection. | Baseline |
| Microbiota qualitative composition modification |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include the above specified study groups.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Tursi, MD, PhD | Contact | +393473490583 | antotursi@tiscali.it | |
| Marcello Picchio, MD | Contact | +393392371293 | marcellopicchio@libero.it |
| Name | Affiliation | Role |
|---|---|---|
| Walter Elisei, MD | • UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Pugliese-Ciaccio | Recruiting | Catanzaro | Calabria | 88100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25874519 | Result | 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. | |
| 35950499 | Result | 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. |
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| ID | Term |
|---|---|
| D004239 | Diverticulitis, Colonic |
| ID | Term |
|---|---|
| D004238 | Diverticulitis |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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Stool
Composition of microbiota will be assessed in symptomatic study groups with a dedicated kit for collection.
| 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. | Baseline and during 6-month follow-up. |
| Concentration of fecal calprotectin | Assessment of fecal calprotectin concentration in the symptomatic study group. | Baseline and during 6-month follow-up. |
| Bristol stool scale modification | Assessment of median Bristol stool scale in the symptomatic study group. | Baseline and during 6-month follow-up. |
| Prevention of recurrent acute diverticulitis | Number off patients with recurrent acute diverticulitis. | Six-month follow-up. |
| Safety | Number of patients with adverse events. | Six-month follow-up. |
| UOSVD di Endoscopia Digestiva, Ospedale "S. Maria Goretti" | Recruiting | Latina | Lazio | 04100 | Italy |
|
| UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini" | Recruiting | Rome | Lazio | 00152 | Italy |
|
| UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I" | Recruiting | Rome | Lazio | 00161 | Italy |
|
| UOC di Medicina Interna e Gastroenterologia, Ospedale "Cristo Re" | Recruiting | Rome | Lazio | 00167 | Italy |
|
| UOC Chirurgia Generale, Ospedale "P. Colombo" | Recruiting | Velletri | Lazio | 00049 | Italy |
|
| UOC di Gastroenterologia, Ospedale "Belcolle", | Recruiting | Viterbo | Lazio | 01100 | Italy |
|
| • UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale Universitario "San Raffaele" | Recruiting | Milan | Lombardy | 20132 | Italy |
|
| UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova | Recruiting | Padova | Lombardy | 35031 | Italy |
|
| UOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto" | Recruiting | Piacenza | Lombardy | 29121 | Italy |
|
| UOC di Gastroenterologia, Ospedale "S. Salvatore", | Recruiting | Pesaro | The Marches | 61121 | Italy |
|
| Gastroenterology Service , ASL BAT, | Recruiting | Andria | 76123 | Italy |
|
| 36499127 | Result | 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. |
| 35602072 | Result | 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. |
| 32523619 | Result | 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. Ther Adv Gastroenterol. 2020 May 8;13:1756284820913210. doi: 10.1177/1756284820913210. eCollection 2020. |
| D004066 |
| Digestive System Diseases |
| D043963 | Diverticulosis, Colonic |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |