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Search / Trial NCT06040515

Probiotic After Acute Colonic Diverticulitis

Launched by ERASMO SPAZIANI · Sep 10, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating whether a specific probiotic called Escherichia coli Nissle 1917 can help reduce symptoms in patients who have recently experienced diverticulitis, an inflammation of the colon. The study aims to understand how effective and safe this probiotic is for people who have had either uncomplicated or complicated diverticulitis. Researchers will look at changes in patients' symptoms, gut bacteria, and other factors over time to see if the probiotic helps improve their condition and prevent future flare-ups.

To participate in the trial, individuals should be between 65 and 74 years old and have symptoms at least three months after an episode of uncomplicated diverticulitis or six months after a complicated case that required surgery. However, people currently experiencing diverticulitis, those on certain medications, or with specific health conditions may not be eligible. Participants will receive the probiotic and will be monitored for any changes in their symptoms and gut health over a period of time. This study could provide valuable insights into how probiotics can aid recovery and improve quality of life for patients with diverticulitis.

Gender

ALL

Eligibility 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.

About Erasmo Spaziani

Erasmo Spaziani is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on rigorous scientific methodology and ethical standards, the organization collaborates with healthcare professionals and institutions to design and implement clinical trials across various therapeutic areas. Erasmo Spaziani prioritizes patient safety and data integrity, leveraging cutting-edge technology and a patient-centered approach to drive breakthroughs in treatment options. Through its strategic partnerships and commitment to excellence, the sponsor aims to contribute significantly to the healthcare landscape and foster the development of novel therapies.

Locations

Andria, , Italy

Catanzaro, Calabria, Italy

Latina, Lazio, Italy

Roma, Lazio, Italy

Roma, Lazio, Italy

Roma, Lazio, Italy

Velletri, Lazio, Italy

Viterbo, Lazio, Italy

Milan, Lombardia, Italy

Padova, Lombardia, Italy

Piacenza, Lombardia, Italy

Pesaro, Marche, Italy

Patients applied

0 patients applied

Trial Officials

Walter Elisei, MD

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported