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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06040515
Other study ID # EcN2023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date June 30, 2024

Study information

Verified date September 2023
Source University of Roma La Sapienza
Contact Antonio Tursi, MD, PhD
Phone +393473490583
Email antotursi@tiscali.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 145
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Probiotic Formula
Capsule with 25 billion live strains of Escherichia coli Nissle 1917

Locations

Country Name City State
Italy Gastroenterology Service , ASL BAT, Andria
Italy 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 ed Endoscopia Digestiva, Ospedale Universitario "San Raffaele" Milan Lombardia
Italy UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova Padova Lombardia
Italy UOC di Gastroenterologia, Ospedale "S. Salvatore", Pesaro Marche
Italy UOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto" Piacenza Lombardia
Italy UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini" Roma Lazio
Italy UOC di Medicina Interna e Gastroenterologia, Ospedale "Cristo Re" Roma Lazio
Italy UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I" Roma Lazio
Italy UOC Chirurgia Generale, Ospedale "P. Colombo" Velletri Lazio
Italy UOC di Gastroenterologia, Ospedale "Belcolle", Viterbo Lazio

Sponsors (1)

Lead Sponsor Collaborator
Erasmo Spaziani

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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;13:17562848209 — View Citation

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. — View Citation

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 2 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Microbiota qualitative composition Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection. Baseline
Secondary Microbiota qualitative composition modification Composition of microbiota will be assessed in symptomatic study groups with a dedicated kit for collection. Baseline and during 6-month follow-up.
Secondary 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.
Secondary Concentration of fecal calprotectin Assessment of fecal calprotectin concentration in the symptomatic study group. Baseline and during 6-month follow-up.
Secondary Bristol stool scale modification Assessment of median Bristol stool scale in the symptomatic study group. Baseline and during 6-month follow-up.
Secondary Prevention of recurrent acute diverticulitis Number off patients with recurrent acute diverticulitis. Six-month follow-up.
Secondary Safety Number of patients with adverse events. Six-month follow-up.
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