About this trial
This prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of Escherichia coli 5C (Colipral®) in adult patients undergoing diagnostic colonoscopy. Participants will be randomized in a 1:1 ratio to receive either Colipral® or placebo for 14 days immediately after colonoscopy. The study aims to determine whether Colipral® reduces post-colonoscopy gastrointestinal symptoms compared with placebo, using validated symptom and stool assessment tools, patient-reported global improvement, and safety monitoring.
Eligibility criteria
Qualifiers
Age between 18 and 80 years
Complete diagnostic colonoscopy with achievement of the cecal fundus
Accepted written informed consent for study participation obtained prior to the start of the study
Disqualifiers
Chronic inflammatory bowel disease
Complicated Diverticular Disease (DICA >3)
Suspected or known colorectal malignancy on index colonoscopy
Diagnosed microscopic colitis
Trial design
Treatments tested in this trial
- Colipral®
- Placebo
Treatment groups
Sponsors and collaborators
Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator