Post-Colonoscopy Gastrointestinal SymptomsNCT07519616
Effect of Escherichia Coli 5C (Colipral®) on Post-Colonoscopy Gastrointestinal Symptoms
A study testing Colipral® in people with Post-Colonoscopy Gastrointestinal Symptoms, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post-Colonoscopy Gastrointestinal Symptoms
- What is being tested?
- Colipral®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
University of Urbino Carlo Bo, Urbino, Italy
Urbino
Prof. Davide Sisti, PhD, davide.sisti@uniurb.it
About this study
Official title: 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.
Read the 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.
- Being tested
- Colipral®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colipral®Dietary supplement
Dietary supplement containing Escherichia coli 5C (Colipral®)
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 7 after colonoscopy
Secondary outcomes (12)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 14 days after colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start27 Apr 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Colonoscopy Gastrointestinal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519616
- Sponsor's protocol ID
- 139_16luglio2025_COLIPRAL
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07519616
- Acronym / sponsor ID
- 139_16luglio2025_COLIPRAL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 27 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Escherichia coli 5C (Colipral®) | Experimental | Dietary Supplement: 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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- Chronic inflammatory bowel disease
- Complicated Diverticular Disease (DICA >3)
- Suspected or known colorectal malignancy on index colonoscopy
- Diagnosed microscopic colitis
- Operative colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colipral®Dietary supplement containing Escherichia coli 5C (Colipral®) | Dietary supplement | Escherichia coli 5C (Colipral®) |
| PlaceboMatching placebo | Other | Placebo |
Primary outcome
Change in Gastrointestinal Symptom Rating Scale (GSRS) score
Time frame: 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.
12 secondary outcomes
Change in Gastrointestinal Symptom Rating Scale (GSRS) total score at Day 14
Time frame: Baseline to Day 14 after colonoscopy
Change in abdominal pain intensity score
Time frame: 48 hours, Day 7, and Day 14 after colonoscopy
Change in abdominal bloating intensity score
Time frame: 48 hours, Day 7, and Day 14 after colonoscopy
Change in flatulence intensity score
Time frame: 48 hours, Day 7, and Day 14 after colonoscopy
Change in stool consistency assessed by Bristol Stool Form Scale
Time frame: 48 hours, Day 7, and Day 14 after colonoscopy
Change in frequency of bowel movements
Time frame: 48 hours, Day 7, and Day 14 after colonoscopy
Global Assessment of Change of Gastrointestinal Symptoms (PGIC) score at Day 7
Time frame: 48 hours, Day 7, and Day 14 after colonoscopy
Proportion of participants with clinically relevant improvement in gastrointestinal symptoms
Time frame: 48 hours, Day 7, and Day 14 after colonoscopy
Use of rescue medication for gastrointestinal symptoms
Time frame: Within 14 days after colonoscopy
Frequency of adverse events
Time frame: Within 14 days after colonoscopy
Treatment tolerability score
Time frame: Day 14 after colonoscopy
Adherence to treatment
Time frame: Within 14 days after colonoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colipral® in people with Post-Colonoscopy Gastrointestinal Symptoms, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gastrointestinal Symptom Rating Scale (GSRS) score (time frame: Baseline to Day 7 after colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.