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

Evaluation of the Effectiveness of Escherichia Coli 5C in the Management of Post-Colonoscopy Symptoms: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post-Colonoscopy Gastrointestinal Symptoms
• Intervention / Treatment: Other: Placebo; Dietary supplement: Colipral®

Detailed Description

Patients undergoing diagnostic colonoscopy may experience gastrointestinal discomfort in the days following the procedure, which may be related to alterations in the intestinal microbiota induced by bowel preparation. This study is designed to evaluate whether supplementation with Escherichia coli 5C (Colipral®) can reduce post-colonoscopy gastrointestinal symptoms compared with placebo.

This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. Adult patients undergoing complete diagnostic colonoscopy will be screened according to predefined inclusion and exclusion criteria and enrolled after written informed consent. Participants will be randomly assigned in a 1:1 ratio to receive either Colipral® or placebo for 14 days immediately following colonoscopy. The study treatment will be administered as 2 capsules per day, with 1 capsule in the morning and 1 capsule in the evening after dinner.

Clinical assessments will be performed at baseline and at 48 hours, 7 days, and 14 days after colonoscopy. The primary efficacy endpoint is the between-group difference in change in Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline to Day 7. Secondary efficacy assessments include GSRS score changes at additional time points, numerical rating scale (NRS) symptom scores, stool consistency, bowel movement frequency, patient global impression of change, use of rescue medication, treatment adherence, tolerability, and adverse events.

The study is designed to assess both the clinical efficacy and safety of Colipral® in the management of post-colonoscopy symptoms in adult patients.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Urbino, Italy
    • University of Urbino Carlo Bo, Urbino, Italy
    • Contact: Prof. Davide Sisti, PhD; Email: davide.sisti@uniurb.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Escherichia coli 5C (Colipral®); Participants in this arm will receive Colipral® (dietary supplement containing Escherichia coli 5C), administered twice daily, with 1 capsule in the morning and 1 capsule in the evening after dinner, for 14 days immediately following colonoscopy.	Dietary supplement: Colipral®; Dietary supplement containing Escherichia coli 5C (Colipral®)
Placebo Comparator: Placebo; Participants in this arm will receive placebo, identical in appearance but not containing the probiotic strain, administered twice daily, with 1 capsule in the morning and 1 capsule in the evening after dinner, for 14 days immediately following colonoscopy.	Other: Placebo; Matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Day 7 after colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to Day 14 after colonoscopy
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.	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.	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.	48 hours, Day 7, and Day 14 after colonoscopy
Change in stool consistency assessed by Bristol Stool Form Scale	Between-group difference in stool consistency assessed using the Bristol Stool Form Scale at 48 hours, Day 7, and Day 14 after colonoscopy.	48 hours, Day 7, and Day 14 after colonoscopy
Change in frequency of bowel movements	Between-group difference in the mean number of daily bowel movements recorded at 48 hours, Day 7, and Day 14 after colonoscopy.	48 hours, Day 7, and Day 14 after colonoscopy
Global Assessment of Change of Gastrointestinal Symptoms (PGIC) score at Day 7	Between-group difference in the Global Assessment of Change of Gastrointestinal Symptoms at Day 7, measured using the Patient Global Impression of Change (PGIC), a 7-category ordinal scale ranging from "Very much worse" to "Very much improved".	48 hours, Day 7, and Day 14 after colonoscopy
Proportion of participants with clinically relevant improvement in gastrointestinal symptoms	Proportion of participants with clinically relevant improvement in gastrointestinal symptoms, defined as a PGIC response of "Improved", assessed at Day 7 and Day 14 after colonoscopy.	48 hours, Day 7, and Day 14 after colonoscopy
Use of rescue medication for gastrointestinal symptoms	Proportion of participants who used concomitant or rescue medication for control of gastrointestinal symptoms within 14 days after colonoscopy. Type of drug, days of intake, and dose will also be recorded.	Within 14 days after colonoscopy
Frequency of adverse events	Frequency and type of adverse events reported within 14 days after colonoscopy, including suspected allergic symptoms, nausea, vomiting, and other clinically relevant events.	Within 14 days after colonoscopy
Treatment tolerability score	Treatment tolerability assessed using a numerical score from 0 to 10 during the 14-day post-colonoscopy period.	Day 14 after colonoscopy
Adherence to treatment	Adherence to study treatment, expressed as the percentage of doses taken compared with those expected during the 14-day observation period.	Within 14 days after colonoscopy

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: University of Urbino "Carlo Bo"

Study record dates

Study Major Dates

• Study Start (Estimated): April 27, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 139_16luglio2025_COLIPRAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No