Probiotic After Acute Colonic Diverticulitis
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ClinicalTrials.gov Identifier: NCT06040515 |
Recruitment Status :
Recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
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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.
Condition or disease | Intervention/treatment |
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Diverticulitis, Colonic Therapy | Drug: Probiotic Formula |
Study Type : | Observational |
Estimated Enrollment : | 145 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Probiotic EcN in Symptomatic Patients After an Episode of Acute Colonic Diverticulitis: a Prospective Multicentre Observational Study. |
Actual Study Start Date : | May 1, 2023 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | June 30, 2024 |
Group/Cohort | Intervention/treatment |
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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
Capsule with 25 billion live strains of Escherichia coli Nissle 1917
Other Name: Escherichia coli Nissle 1917 |
Diverticulosis
Patients with asymptomatic diverticulosis. No therapy will be administered. Microbiota assessment will be performed.
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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.
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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.
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- 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
- Microbiota qualitative composition [ Time Frame: Baseline ]Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection.
- Microbiota qualitative composition modification [ Time Frame: Baseline and during 6-month follow-up. ]Composition of microbiota will be assessed in symptomatic study groups with a dedicated kit for collection.
- Microbiota qualitative composition and median symptomatic score correlation [ Time Frame: Baseline and during 6-month follow-up. ]Correlation between the median symptomatic score and qualitative composition of microbiota modification after therapy.
- Concentration of fecal calprotectin [ Time Frame: Baseline and during 6-month follow-up. ]Assessment of fecal calprotectin concentration in the symptomatic study group.
- Bristol stool scale modification [ Time Frame: Baseline and during 6-month follow-up. ]Assessment of median Bristol stool scale in the symptomatic study group.
- Prevention of recurrent acute diverticulitis [ Time Frame: Six-month follow-up. ]Number off patients with recurrent acute diverticulitis.
- Safety [ Time Frame: Six-month follow-up. ]Number of patients with adverse events.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06040515
Contact: Antonio Tursi, MD, PhD | +393473490583 | antotursi@tiscali.it | |
Contact: Marcello Picchio, MD | +393392371293 | marcellopicchio@libero.it |
Italy | |
UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Pugliese-Ciaccio | Recruiting |
Catanzaro, Calabria, Italy, 88100 | |
Contact: Stefano Rodinò, MD, PhD srodino@tin.it | |
UOSVD di Endoscopia Digestiva, Ospedale "S. Maria Goretti" | Recruiting |
Latina, Lazio, Italy, 04100 | |
Contact: Giuseppe Pianese pianesepino@libero.it | |
UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini" | Recruiting |
Roma, Lazio, Italy, 00152 | |
Contact: Roberto Faggiani, MD, PhD faggiani.r@tin.it | |
UOSVD di Gastroenterologia ed Endoscopia Digestiva, Ospedale "Umberto I" | Recruiting |
Roma, Lazio, Italy, 00161 | |
Contact: Antonio Cuomo, MD, PhD drcuomo@iol.it | |
UOC di Medicina Interna e Gastroenterologia, Ospedale "Cristo Re" | Recruiting |
Roma, Lazio, Italy, 00167 | |
Contact: Giovanni Brandimarte, MD, PhD giovannibrandimarte56@gmail.com | |
UOC Chirurgia Generale, Ospedale "P. Colombo" | Recruiting |
Velletri, Lazio, Italy, 00049 | |
Contact: Marcello Picchio, MD marcellopicchio@libero.it | |
UOC di Gastroenterologia, Ospedale "Belcolle", | Recruiting |
Viterbo, Lazio, Italy, 01100 | |
Contact: Costantino Zampaletta zcosta@libero.it | |
• UOC di Gastroenterologia ed Endoscopia Digestiva, Ospedale Universitario "San Raffaele" | Recruiting |
Milan, Lombardia, Italy, 20132 | |
Contact: Silvio Danese, MD, PhD sdanese@hotmail.com | |
UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova | Recruiting |
Padova, Lombardia, Italy, 35031 | |
Contact: Edoardo V. Savarino, MD, PhD edoardo.savarino@unipd.it | |
UOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto" | Recruiting |
Piacenza, Lombardia, Italy, 29121 | |
Contact: Giovanni Aragona, MD, PhD g.aragona@ausl.pc.it | |
UOC di Gastroenterologia, Ospedale "S. Salvatore", | Recruiting |
Pesaro, Marche, Italy, 61121 | |
Contact: Antonella Scarcelli, MD antonella.scarcelli@ospedalimarchenord.it | |
Gastroenterology Service , ASL BAT, | Recruiting |
Andria, Italy, 76123 | |
Contact: Antonio Tursi, MD antotursi@tiscali.it |
Principal Investigator: | Walter Elisei, MD | • UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma |
Responsible Party: | Erasmo Spaziani, MD, PhD, University of Roma La Sapienza |
ClinicalTrials.gov Identifier: | NCT06040515 |
Other Study ID Numbers: |
EcN2023 |
First Posted: | September 15, 2023 Key Record Dates |
Last Update Posted: | September 15, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Diverticulitis Diverticulitis, Colonic Diverticular Diseases Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Diverticulosis, Colonic Colonic Diseases Intestinal Diseases |