Diverticulitis, ColonicNCT06040515
Probiotic After Acute Colonic Diverticulitis
An observational study of Diverticulitis, Colonic and Therapy, run by Erasmo Spaziani at 12 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis, Colonic, Therapy
- What is being tested?
- Probiotic Formula
- Type of treatment
- Pill or oral medicine
- How many people
- 145 participants
- Where
- 12 sitesItaly
- Study dates
- 1 May 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include the above specified study groups.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites, 12 recruiting
- Recruiting
Gastroenterology Service , ASL BAT,
Andria, 76123
Antonio Tursi, MD, antotursi@tiscali.it
- Recruiting
UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Pugliese-Ciaccio
Catanzaro, Calabria, 88100
Stefano Rodinò, MD, PhD, srodino@tin.it
- Recruiting
UOSVD di Endoscopia Digestiva, Ospedale "S. Maria Goretti"
Latina, Lazio, 04100
Giuseppe Pianese, pianesepino@libero.it
- Recruiting
• UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale Universitario "San Raffaele"
Milan, Lombardy, 20132
Silvio Danese, MD, PhD, sdanese@hotmail.com
- Recruiting
UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova
Padova, Lombardy, 35031
Edoardo V. Savarino, MD, PhD, edoardo.savarino@unipd.it
- Recruiting
UOC di Gastroenterologia, Ospedale "S. Salvatore",
Pesaro, The Marches, 61121
Antonella Scarcelli, MD, antonella.scarcelli@ospedalimarchenord.it
- Recruiting
UOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto"
Piacenza, Lombardy, 29121
Giovanni Aragona, MD, PhD, g.aragona@ausl.pc.it
- Recruiting
UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini"
Rome, Lazio, 00152
Roberto Faggiani, MD, PhD, faggiani.r@tin.it
- Recruiting
UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I"
Rome, Lazio, 00161
Antonio Cuomo, MD, PhD, drcuomo@iol.it
- Recruiting
UOC di Medicina Interna e Gastroenterologia, Ospedale "Cristo Re"
Rome, Lazio, 00167
Giovanni Brandimarte, MD, PhD, giovannibrandimarte56@gmail.com
- Recruiting
UOC Chirurgia Generale, Ospedale "P. Colombo"
Velletri, Lazio, 00049
Marcello Picchio, MD, marcellopicchio@libero.it
- Recruiting
UOC di Gastroenterologia, Ospedale "Belcolle",
Viterbo, Lazio, 01100
Costantino Zampaletta, zcosta@libero.it
About this study
Official title: Probiotic EcN in Symptomatic Patients After an Episode of Acute Colonic Diverticulitis: a Prospective Multicentre Observational Study.
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
- Being tested
- Probiotic Formula
- Medical subject headings
- Diverticulitis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic FormulaDrug
Also called Escherichia coli Nissle 1917
Capsule with 25 billion live strains of Escherichia coli Nissle 1917
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917
Median symptomatic score assessed at baseline and during follow-up
Measured: Six-months follow-up
Secondary outcomes (7)
Microbiota qualitative composition
Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection.
Measured: Baseline
Microbiota qualitative composition modification
Composition of microbiota will be assessed in symptomatic study groups with a dedicated kit for collection.
Measured: 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.
Measured: Baseline and during 6-month follow-up.
Concentration of fecal calprotectin
Assessment of fecal calprotectin concentration in the symptomatic study group.
Measured: Baseline and during 6-month follow-up.
Bristol stool scale modification
Assessment of median Bristol stool scale in the symptomatic study group.
Measured: Baseline and during 6-month follow-up.
Prevention of recurrent acute diverticulitis
Number off patients with recurrent acute diverticulitis.
Measured: Six-month follow-up.
Safety
Number of patients with adverse events.
Measured: Six-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 May 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diverticulitis, ColonicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmo Spaziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erasmo Spaziani, University of Roma La Sapienza
- Investigators
- Walter Elisei, MD, Principal investigator, • UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040515
- Sponsor's protocol ID
- EcN2023
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25874519Mj 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.
PubMed 35950499Tursi 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.
PubMed 36499127Teng 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.
PubMed 35602072Lahat 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.
PubMed 32523619
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic EcN in Symptomatic Patients After an Episode of Acute Colonic Diverticulitis: a Prospective Multicentre Observational Study.
- ClinicalTrials.gov ID
- NCT06040515
- Acronym / sponsor ID
- EcN2023
- Conditions
- Diverticulitis, Colonic, Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Erasmo SpazianiUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Symptomatic patients after acute diverticulitis | – | Drug: Probiotic FormulaPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include the above specified study groups.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic FormulaAlso: Escherichia coli Nissle 1917Capsule with 25 billion live strains of Escherichia coli Nissle 1917 | Drug | Symptomatic patients after acute diverticulitis |
Primary outcome
Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917
Time frame: Six-months follow-up
Median symptomatic score assessed at baseline and during follow-up
7 secondary outcomes
Microbiota qualitative composition
Time frame: Baseline
Microbiota qualitative composition modification
Time frame: Baseline and during 6-month follow-up.
Microbiota qualitative composition and median symptomatic score correlation
Time frame: Baseline and during 6-month follow-up.
Concentration of fecal calprotectin
Time frame: Baseline and during 6-month follow-up.
Bristol stool scale modification
Time frame: Baseline and during 6-month follow-up.
Prevention of recurrent acute diverticulitis
Time frame: Six-month follow-up.
Safety
Time frame: Six-month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Results publication: PubMed 25874519Kvasnovsky 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.
- Results publication: PubMed 35950499Mj 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.
- Results publication: PubMed 36499127Tursi 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.
- Results publication: PubMed 35602072Teng 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.
- Results publication: PubMed 32523619Lahat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Elisei, MD principal investigator
• UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticulitis, Colonic and Therapy, run by Erasmo Spaziani at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Tursi, MD, PhD (+393473490583, antotursi@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median symptomatic score reduction after therapy with Escherichia coli Nissle 1917 (time frame: Six-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06040515, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023; AzTrials last refreshed its copy on 27 Oct 2026.