Effect of Escherichia Coli 5C (Colipral®) on Post-Colonoscopy Gastrointestinal Symptoms

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLiaquat University of Medical & Health Sciences

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

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Liaquat University of Medical & Health Sciences

Lead sponsor

University of Urbino "Carlo Bo"

Collaborator