Probiotic After Acute Colonic Diverticulitis

Last updated: September 10, 2023
Sponsor: Erasmo Spaziani
Overall Status: Active - Recruiting

Phase

N/A

Condition

Intra-abdominal Infections

Treatment

Probiotic Formula

Clinical Study ID

NCT06040515
EcN2023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic patients three months after an episode of uncomplicated acute colonicdiverticulitis;
  • Symptomatic patients six months after an episode of complicated acute colonicdiverticulitis; submitted to .surgical colonic resection without stoma;
  • Patients with diverticulosis;
  • Asymptomatic patients three months after an episode of uncomplicated acute colonicdiverticulitis;
  • Asymptomatic patients six months after an episode of complicated acute colonicdiverticulitis; submitted to surgical colonic resection without stoma.

Exclusion

Exclusion Criteria:

  • Ongoing acute diverticulitis at radiologic assessment
  • Antibiotic therapy, both systemic and topic, and/or probiotics and/or mesalazinewithin 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 monthsbefore enrolment;
  • Presence of COVID-19 infection;
  • Patients unable to give informed consent.

Study Design

Total Participants: 145
Treatment Group(s): 1
Primary Treatment: Probiotic Formula
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
June 30, 2024

Connect with a study center

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

    Catanzaro, Calabria 88100
    Italy

    Active - Recruiting

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

    Latina, Lazio 04100
    Italy

    Active - Recruiting

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

    Roma, Lazio 00152
    Italy

    Active - Recruiting

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

    Roma, Lazio 00167
    Italy

    Active - Recruiting

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

    Roma, Lazio 00161
    Italy

    Active - Recruiting

  • UOC Chirurgia Generale, Ospedale "P. Colombo"

    Velletri, Lazio 00049
    Italy

    Active - Recruiting

  • UOC di Gastroenterologia, Ospedale "Belcolle",

    Viterbo, Lazio 01100
    Italy

    Active - Recruiting

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

    Milan, Lombardia 20132
    Italy

    Active - Recruiting

  • UOC di Gastroenterologia Azienda Ospedaliero-Universitaria di Padova

    Padova, Lombardia 35031
    Italy

    Active - Recruiting

  • UOC di Gastroenterologia, Ospedale "Guglielmo da Saliceto"

    Piacenza, Lombardia 29121
    Italy

    Active - Recruiting

  • UOC di Gastroenterologia, Ospedale "S. Salvatore",

    Pesaro, Marche 61121
    Italy

    Active - Recruiting

  • Gastroenterology Service , ASL BAT,

    Andria, 76123
    Italy

    Active - Recruiting

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