Post-Colonoscopy Gastrointestinal Symptoms
Conditions
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.
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.
Interventions
DIETARY_SUPPLEMENTColipral®
Dietary supplement containing Escherichia coli 5C (Colipral®)
OTHERPlacebo
Matching placebo
Sponsors
Liaquat University of Medical & Health Sciences
University of Urbino "Carlo Bo"
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Symptom Rating Scale (GSRS) total score at Day 14 | Baseline to Day 14 after colonoscopy | Between-group difference in change in gastrointestinal symptom severity from baseline to Day 14 after colonoscopy, assessed using the Gastrointestinal Symptom Rating Scale (GSRS). |
| Change in abdominal pain intensity score | 48 hours, Day 7, and Day 14 after colonoscopy | 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. |
| Change in abdominal bloating intensity score | 48 hours, Day 7, and Day 14 after colonoscopy | 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. |
| Change in flatulence intensity score | 48 hours, Day 7, and Day 14 after colonoscopy | 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. |
| Change in stool consistency assessed by Bristol Stool Form Scale | 48 hours, Day 7, and Day 14 after colonoscopy | Between-group difference in stool consistency assessed using the Bristol Stool Form Scale at 48 hours, Day 7, and Day 14 after colonoscopy. |
| Change in frequency of bowel movements | 48 hours, Day 7, and Day 14 after colonoscopy | Between-group difference in the mean number of daily bowel movements recorded at 48 hours, Day 7, and Day 14 after colonoscopy. |
| Global Assessment of Change of Gastrointestinal Symptoms (PGIC) score at Day 7 | 48 hours, Day 7, and Day 14 after colonoscopy | 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". |
| Proportion of participants with clinically relevant improvement in gastrointestinal symptoms | 48 hours, Day 7, and Day 14 after colonoscopy | 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. |
| Use of rescue medication for gastrointestinal symptoms | Within 14 days after colonoscopy | 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. |
| Frequency of adverse events | Within 14 days after colonoscopy | Frequency and type of adverse events reported within 14 days after colonoscopy, including suspected allergic symptoms, nausea, vomiting, and other clinically relevant events. |
| Treatment tolerability score | Day 14 after colonoscopy | Treatment tolerability assessed using a numerical score from 0 to 10 during the 14-day post-colonoscopy period. |
| Adherence to treatment | Within 14 days after colonoscopy | Adherence to study treatment, expressed as the percentage of doses taken compared with those expected during the 14-day observation period. |
Countries
Italy
Outcome results
None listed