Assessment of the Efficacy of E. Coli 5C in the Management of Post-Colonoscopy Symptoms

Assessment of the Efficacy of E. Coli 5C in the Management of Post-colonoscopy Symptoms: a Randomised, Double-blind, Placebo-controlled Trial.

This prospective, 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, 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, with patient global impression of change and clinically relevant improvement assessed only at Day 7 and Day 14. The primary efficacy endpoint is the between-group difference in change in Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline to Day 14. Secondary assessments include numerical rating scale (NRS) symptom scores, stool consistency, bowel movement frequency, patient global impression of change, clinically relevant improvement in gastrointestinal symptoms, 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 Contact: Name: Davide Sisti, PhD; Phone Number: +39 0722 303301; Email: davide.sisti@uniurb.it

Study Locations

• Italy
  • Roma, Italy, 00191
    • Clinica ARS Biomedica - Via Luigi Bodio 58
    • Contact: Dr. Fabrizio Ficuccilli's, MD; Phone Number: +39 06 3614941; Email: info@arsbiomedica.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged between 18 and 80 years;
• Must have undergone a full colonoscopy on the date of enrolment.

Exclusion Criteria:

• Chronic Inflammatory Bowel Disease
• Complicated Diverticular Disease (DICA classification >3)
• Neoplastic disease of the colon
• Diagnosed microscopic colitis
• Therapeutic colonoscopy
• Immunocompromised patients (primary immunodeficiency, cancer undergoing active chemotherapy or immunotherapy, autoimmune disease undergoing immunosuppressive treatment)

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) 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 and Day 14	Between-group difference in the Global Assessment of Change of Gastrointestinal Symptoms at Day 7 and Day 14, measured using the Patient Global Impression of Change (PGIC), a 7-category ordinal scale ranging from "Very much worse" to "Very much improved".	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.	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): November 16, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: November 6, 2026
• First Submitted That Met QC Criteria: November 6, 2026
• First Posted (Actual): November 12, 2026

Study Record Updates

• Last Update Posted (Actual): November 12, 2026
• Last Update Submitted That Met QC Criteria: November 6, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 139_16luglio2025_COLIPRAL_SIST

Drug and device information, study documents

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