Clinical trial NCT06040515: Probiotic After Acute Colonic Diverticulitis
Official title: Probiotic EcN in Symptomatic Patients After an Episode of Acute Colonic Diverticulitis: a Prospective Multicentre Observational Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diverticulitis, Colonic
Therapy
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include the above specified study groups.

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917
timeFrame: Six-months follow-up
Secondary outcomes:
measure: Microbiota qualitative composition
timeFrame: Baseline
measure: Microbiota qualitative composition modification
timeFrame: Baseline and during 6-month follow-up.
measure: Microbiota qualitative composition and median symptomatic score correlation
timeFrame: Baseline and during 6-month follow-up.
measure: Concentration of fecal calprotectin
timeFrame: Baseline and during 6-month follow-up.
measure: Bristol stool scale modification
timeFrame: Baseline and during 6-month follow-up.
measure: Prevention of recurrent acute diverticulitis
timeFrame: Six-month follow-up.
measure: Safety
timeFrame: Six-month follow-up.
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Pugliese-Ciaccio
state: Calabria
city: Latina
country: Italy
facility: UOSVD di Endoscopia Digestiva, Ospedale "S. Maria Goretti"
state: Lazio
city: Roma
country: Italy
facility: UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini"
state: Lazio
city: Roma
country: Italy
facility: UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I"
state: Lazio
city: Roma
country: Italy
facility: UOC di Medicina Interna e Gastroenterologia, Ospedale "Cristo Re"
state: Lazio
city: Velletri
country: Italy
facility: UOC Chirurgia Generale, Ospedale "P. Colombo"
state: Lazio
city: Viterbo
country: Italy
facility: UOC di Gastroenterologia, Ospedale "Belcolle",
state: Lazio
city: Milan
country: Italy
facility: • UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale Universitario "San Raffaele"
state: Lombardia
city: Padova
country: Italy
facility: UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova
state: Lombardia
city: Piacenza
country: Italy
facility: UOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto"
state: Lombardia
city: Pesaro
country: Italy
facility: UOC di Gastroenterologia, Ospedale "S. Salvatore",
state: Marche
city: Andria
country: Italy
facility: Gastroenterology Service , ASL BAT,
Study officials:
affiliation: • UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma
name: Walter Elisei, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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 2022.
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;13:1756284820913210. doi: 10.1177/1756284820913210. eCollection 2020.