Probiotic After Acute Colonic Diverticulitis

Therapy Clinical Trial

Official title:

Probiotic EcN in Symptomatic Patients After an Episode of Acute Colonic Diverticulitis: a Prospective Multicentre Observational Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040515
• Other study ID #: EcN2023
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulitis, Colonic
• Therapy

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.