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

NCT07519616 · tracked via the Priya Life Science Italy tracker

Sponsor

Liaquat University of Medical & Health Sciences

Phase

Not applicable

Started

2026-04-27

Last updated

2026-04-09

Condition(s) studied

Post-Colonoscopy Gastrointestinal Symptoms

Investigational drug(s) / intervention(s)

Colipral®Placebo

Colipral®: Dietary supplement containing Escherichia coli 5C (Colipral®)

Placebo: Matching placebo

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Change in Gastrointestinal Symptom Rating Scale (GSRS) score — Baseline to Day 7 after colonoscopy
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.

Trial sites (1)

Facility	City	Region	Status
University of Urbino Carlo Bo, Urbino, Italy	Urbino	Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07519616 on ClinicalTrials.gov ↗ ← All trials in Italy