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

NCT07519616 | Not Yet Recruiting DMC

• 1 other identifier: 139_16luglio2025_COLIPRAL
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Post-Colonoscopy Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in Gastrointestinal Symptom Rating Scale (GSRS) total score at Day 14

  Baseline to Day 14 after colonoscopy

• Change in abdominal pain intensity score

  48 hours, Day 7, and Day 14 after colonoscopy

• Change in abdominal bloating intensity score

  48 hours, Day 7, and Day 14 after colonoscopy

• Change in flatulence intensity score

  48 hours, Day 7, and Day 14 after colonoscopy

• Change in stool consistency assessed by Bristol Stool Form Scale

  48 hours, Day 7, and Day 14 after colonoscopy

Study Arms (2)

Escherichia coli 5C (Colipral®)

EXPERIMENTAL

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®

Placebo

PLACEBO COMPARATOR

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

Interventions

Colipral® DIETARY_SUPPLEMENT

Dietary supplement containing Escherichia coli 5C (Colipral®)

Escherichia coli 5C (Colipral®)

Placebo OTHER

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• University of Urbino "Carlo Bo": collaborator

Study Sites (1)

University of Urbino Carlo Bo, Urbino, Italy

Urbino, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study. Participants, care providers, investigators, and outcome assessors will remain blinded to treatment allocation throughout the study. Active product and placebo will be matched in appearance and administration schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned in a parallel-group design to receive either Escherichia coli 5C (Colipral®) or matching placebo following colonoscopy. Study products will be administered for 14 days after the procedure, and outcomes will be assessed prospectively over the post-colonoscopy follow-up period.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

IT (1)