Probiotic After Acute Colonic Diverticulitis

NCT06040515 | Unknown

• 1 other identifier: EcN2023
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 12

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.

Conditions

Diverticulitis, Colonic; Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Microbiota qualitative composition

  Baseline

• Microbiota qualitative composition modification

  Baseline and during 6-month follow-up.

• Microbiota qualitative composition and median symptomatic score correlation

  Baseline and during 6-month follow-up.

• Concentration of fecal calprotectin

  Baseline and during 6-month follow-up.

• Bristol stool scale modification

  Baseline and during 6-month follow-up.

Study Arms (4)

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.

Drug: Probiotic Formula

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.

Interventions

Probiotic Formula DRUG

Capsule with 25 billion live strains of Escherichia coli Nissle 1917

Also known as: Escherichia coli Nissle 1917

Symptomatic patients after acute diverticulitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include the above specified study groups.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmo Spaziani: lead

Study Sites (12)

UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Pugliese-Ciaccio

Catanzaro, Calabria, 88100, Italy

RECRUITING

UOSVD di Endoscopia Digestiva, Ospedale "S. Maria Goretti"

Latina, Lazio, 04100, Italy

RECRUITING

UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini"

Rome, Lazio, 00152, Italy

RECRUITING

UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I"

Rome, Lazio, 00161, Italy

RECRUITING

UOC di Medicina Interna e Gastroenterologia, Ospedale "Cristo Re"

Rome, Lazio, 00167, Italy

RECRUITING

UOC Chirurgia Generale, Ospedale "P. Colombo"

Velletri, Lazio, 00049, Italy

RECRUITING

UOC di Gastroenterologia, Ospedale "Belcolle",

Viterbo, Lazio, 01100, Italy

RECRUITING

• UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale Universitario "San Raffaele"

Milan, Lombardy, 20132, Italy

RECRUITING

UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova

Padova, Lombardy, 35031, Italy

RECRUITING

UOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto"

Piacenza, Lombardy, 29121, Italy

RECRUITING

UOC di Gastroenterologia, Ospedale "S. Salvatore",

Pesaro, The Marches, 61121, Italy

RECRUITING

Gastroenterology Service , ASL BAT,

Andria, 76123, Italy

RECRUITING

Related 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.

  PMID: 25874519 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.

  PMID: 35950499 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.

  PMID: 36499127 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.

  PMID: 35602072 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. Therap Adv Gastroenterol. 2020 May 8;13:1756284820913210. doi: 10.1177/1756284820913210. eCollection 2020.

  PMID: 32523619 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Stool

MeSH Terms

Conditions

Diverticulitis, Colonic

Condition Hierarchy (Ancestors)

Diverticulitis; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases

Study Officials

• Walter Elisei, MD

  • UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Tursi, MD, PhD

CONTACT

+393473490583; antotursi@tiscali.it

Marcello Picchio, MD

CONTACT

+393392371293; marcellopicchio@libero.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 15, 2023
• Study Start: May 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (12)