An interventional study of Colipral® and Placebo in Post-Colonoscopy Gastrointestinal Symptoms, sponsored by Liaquat University of Medical & Health Sciences. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Treatment
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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.
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.
Liaquat University of Medical & Health Sciences is the lead sponsor of 57 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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®
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
Dietary supplement containing Escherichia coli 5C (Colipral®)
Matching placebo
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 14 days after colonoscopy
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Liaquat University of Medical & Health Sciences