Effect of Escherichia Coli 5C (Colipral®) on Post-Colonoscopy Gastrointestinal Symptoms (NCT07519616) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Escherichia Coli 5C (Colipral®) on Post-Colonoscopy Gastrointestinal Symptoms
Italy160 participantsStarted 2026-04-27
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* Chronic inflammatory bowel disease
* Complicated Diverticular Disease (DICA \>3)
* Suspected or known colorectal malignancy on index colonoscopy
* Diagnosed microscopic colitis
* Operative colonoscopy
* Severe chronic gastrointestinal symptoms judged by the investigator to interfere with the evaluation of study endpoints
* Subjects who are immunosuppressed or on systemic immunosuppressive treatment, including patients with primary or acquired immunodeficiency, oncological disease on active treatment with chemotherapy/immunotherapy, or autoimmune diseases on immunosuppressive treatment
* Taking probiotics, prebiotics, or synbiotics within 2-4 weeks prior to enrollment
* Antibiotic therapy within 4 weeks prior to enrollment
* Lack of acceptance of written informed consent
What they're measuring
1
Change in Gastrointestinal Symptom Rating Scale (GSRS) score
Timeframe: Baseline to Day 7 after colonoscopy
Trial details
NCT IDNCT07519616
SponsorLiaquat University of Medical & Health Sciences