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Probiotic After Acute Colonic Diverticulitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06040515
Recruitment Status : Recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
Erasmo Spaziani, University of Roma La Sapienza

Study Description
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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.

Condition or disease Intervention/treatment
Diverticulitis, Colonic Therapy Drug: Probiotic Formula

Study Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Microbiota qualitative composition [ Time Frame: Baseline ]
    Composition of microbiota will be assessed in all the study groups with a dedicated kit for collection.

  2. 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.

  3. 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.

  4. Concentration of fecal calprotectin [ Time Frame: Baseline and during 6-month follow-up. ]
    Assessment of fecal calprotectin concentration in the symptomatic study group.

  5. Bristol stool scale modification [ Time Frame: Baseline and during 6-month follow-up. ]
    Assessment of median Bristol stool scale in the symptomatic study group.

  6. Prevention of recurrent acute diverticulitis [ Time Frame: Six-month follow-up. ]
    Number off patients with recurrent acute diverticulitis.

  7. Safety [ Time Frame: Six-month follow-up. ]
    Number of patients with adverse events.


Biospecimen Retention:   Samples With DNA
Stool

Eligibility Criteria
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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
Study Population
The study population will include the above specified study groups.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Antonio Tursi, MD, PhD +393473490583 antotursi@tiscali.it
Contact: Marcello Picchio, MD +393392371293 marcellopicchio@libero.it

Locations
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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   
Sponsors and Collaborators
Erasmo Spaziani
Investigators
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Principal Investigator: Walter Elisei, MD • UOC di Gastroenterologia, Azienda Ospedaliera "S. Camillo-Forlanini", Roma
More Information
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Publications of Results:

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticulitis
Diverticulitis, Colonic
Diverticular Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Diverticulosis, Colonic
Colonic Diseases
Intestinal Diseases