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.
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
Chronic inflammatory bowel disease
Complicated Diverticular Disease (DICA >3)
Suspected or known colorectal malignancy on index colonoscopy
Diagnosed microscopic colitis
Parallel
Colipral®
Dietary supplementDietary supplement containing Escherichia coli 5C (Colipral®)
Placebo
Other interventionMatching placebo
Change in Gastrointestinal Symptom Rating Scale (GSRS) score
Change in gastrointestinal symptoms from baseline to Day 7 after colonoscopy, assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a validated questionnaire used to evaluate gastrointestinal symptom severity.
Change in Gastrointestinal Symptom Rating Scale (GSRS) total score at Day 14
Between-group difference in change in gastrointestinal symptom severity from baseline to Day 14 after colonoscopy, assessed using the Gastrointestinal Symptom Rating Scale (GSRS).
Change in abdominal pain intensity score
Between-group difference in abdominal pain intensity assessed using a Numerical Rating Scale (NRS, 0-10), with higher scores indicating greater symptom intensity, at 48 hours, Day 7, and Day 14 after colonoscopy.
Change in abdominal bloating intensity score
Between-group difference in abdominal bloating intensity assessed using a Numerical Rating Scale (NRS, 0-10), with higher scores indicating greater symptom intensity, at 48 hours, Day 7, and Day 14 after colonoscopy.
Change in flatulence intensity score
Between-group difference in flatulence intensity assessed using a Numerical Rating Scale (NRS, 0-10), with higher scores indicating greater symptom intensity, at 48 hours, Day 7, and Day 14 after colonoscopy.
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Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
