Bowel Cleansing for ColonoscopyNCT07557173
Comparing Three Rescue Bowel Preparation Regimens for Colonoscopy After Failed Cleansing
A study testing Drug in people with Bowel Cleansing for Colonoscopy and Inadequate Bowel Preparation, run by Ospedale San Pio at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn which rescue bowel preparation works best for adults who need a repeat colonoscopy after a previous bowel preparation did not clean the bowel well enough. The study will also look at how satisfied participants are with each preparation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Cleansing for Colonoscopy, Inadequate Bowel Preparation
- What is being tested?
- Drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2024to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Prior inadequate bowel preparation (adequately performed) requiring repeat colonoscopy
- Scheduled to undergo repeat outpatient colonoscopy
- Ability to provide informed consent
Who cannot join
- Age younger than 18 years
- Inability to provide informed consent
- Contraindication to any study bowel preparation regimen or colonoscopy
- Known or suspected bowel obstruction or severe gastrointestinal motility disorder
- Pregnancy or breastfeeding
- Participation considered inappropriate by the investigators for clinical or safety reasons
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, 1 recruiting
- Recruiting
San Pio Hospital
Benevento
Giuseppe Scaglione, MD, +39 360638237, giuseppe.scaglione@aornsanpio.it
About this study
Official title: Comparison of Three Different Rescue Bowel Preparation Regimens in Patients With Previous Bowel Cleansing Failure at Colonoscopy
The goal of this clinical trial is to learn which rescue bowel preparation works best for adults who need a repeat colonoscopy after a previous bowel preparation did not clean the bowel well enough. The study will also look at how satisfied participants are with each preparation. The main questions it aims to answer are:
- Which bowel preparation helps more participants achieve adequate bowel cleansing before repeat colonoscopy?
- Which bowel preparation leads to better cleansing in different parts of the colon?
- Which bowel preparation is better tolerated by participants?
Read more
Researchers will compare 3 rescue bowel preparation regimens to see which one works best for repeat colonoscopy after a previous cleansing failure.
Participants will:
- be randomly assigned to 1 of 3 bowel preparation regimens
- take one of the following regimens before repeat colonoscopy:
- 4 liters of polyethylene glycol (PEG) plus 12 milligrams of bisacodyl
- 1 liter of PEG plus ascorbic acid plus 10 milligrams of bisacodyl
- 2 liters of PEG plus extra PEG taken over the 3 days before colonoscopy
- undergo repeat colonoscopy
- rate their satisfaction with the bowel preparation
- Being tested
- Drug
- Keywords
- Rescue bowel preparation, Bowel preparation, Colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrugDrug
Also called SELG ESSE, Bisacodyl
4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy.
DrugDrug
Also called Plenvu, Bisacodyl
1 liter of polyethylene glycol plus ascorbic acid and bisacodyl 10 mg administered as rescue bowel preparation before repeat colonoscopy.
DrugDrug
Also called Clensia
2 liters of polyethylene glycol plus additional polyethylene glycol administered during the 3 days before repeat colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 4 L PEG + bisacodyl | Active comparator | Participants receive 4 L polyethylene glycol (PEG) plus bisacodyl 12 mg before repeat colonoscopy after prior inadequate bowel preparation. Receives: Drug: Drug |
| 1 L PEG plus ascorbic acid + bisacodyl | Active comparator | Participants receive 1 L polyethylene glycol (PEG) plus ascorbic acid and bisacodyl 10 mg before repeat colonoscopy after prior inadequate bowel preparation. Receives: Drug: Drug |
| 2 L PEG + additional PEG | Active comparator | Participants receive 2 L polyethylene glycol (PEG) plus additional PEG administered during the 3 days before repeat colonoscopy after prior inadequate bowel preparation. Receives: Drug: Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate bowel preparation at repeat colonoscopy
Proportion of participants with adequate bowel preparation at repeat colonoscopy, defined as a Boston Bowel Preparation Scale (BBPS) total score of 6 or higher, with a score of at least 2 in each colonic segment.
Measured: At repeat colonoscopy, on the day of the procedure
Secondary outcomes (6)
Total Boston Bowel Preparation Scale score at repeat colonoscopy
Mean total Boston Bowel Preparation Scale (BBPS) score assessed at repeat colonoscopy. The BBPS ranges from 0 to 9, with higher scores indicating better bowel cleansing.
Measured: At repeat colonoscopy, on the day of the procedure
Right colon Boston Bowel Preparation Scale subscore
Mean BBPS subscore for the right colon assessed at repeat colonoscopy. Segment scores range from 0 to 3, with higher scores indicating better bowel cleansing.
Measured: At repeat colonoscopy, on the day of the procedure
Transverse colon Boston Bowel Preparation Scale subscore
Mean BBPS subscore for the transverse colon assessed at repeat colonoscopy. Segment scores range from 0 to 3, with higher scores indicating better bowel cleansing.
Measured: At repeat colonoscopy, on the day of the procedure
Left colon Boston Bowel Preparation Scale subscore
Mean BBPS subscore for the left colon assessed at repeat colonoscopy. Segment scores range from 0 to 3, with higher scores indicating better bowel cleansing.
Measured: At repeat colonoscopy, on the day of the procedure
Participant satisfaction with bowel preparation
Participant-reported satisfaction with the assigned bowel preparation regimen, measured using a numerical rating scale. Higher scores indicate greater satisfaction.
Measured: Assessed after bowel preparation and before or at repeat colonoscopy, on the day of the procedure
Polyp detection at repeat colonoscopy
Proportion of participants with at least 1 polyp detected during repeat colonoscopy.
Measured: At repeat colonoscopy, on the day of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start2 Jan 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel Cleansing for ColonoscopyStudies 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 are randomly assigned in a 1:1:1 ratio to 1 of 3 rescue bowel preparation regimens before repeat colonoscopy after prior inadequate bowel preparation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Pio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Scaglione, Ospedale San Pio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557173
- Sponsor's protocol ID
- CECN/2116
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Different Rescue Bowel Preparation Regimens in Patients With Previous Bowel Cleansing Failure at Colonoscopy
- ClinicalTrials.gov ID
- NCT07557173
- Acronym / sponsor ID
- CECN/2116
- Keywords
- Rescue bowel preparation, Bowel preparation, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Ospedale San PioUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 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.
The goal of this clinical trial is to learn which rescue bowel preparation works best for adults who need a repeat colonoscopy after a previous bowel preparation did not clean the bowel well enough. The study will also look at how satisfied participants are with each preparation. The main questions it aims to answer are:
- Which bowel preparation helps more participants achieve adequate bowel cleansing before repeat colonoscopy?
- Which bowel preparation leads to better cleansing in different parts of the colon?
- Which bowel preparation is better tolerated by participants?
Researchers will compare 3 rescue bowel preparation regimens to see which one works best for repeat colonoscopy after a previous cleansing failure.
Participants will:
- be randomly assigned to 1 of 3 bowel preparation regimens
- take one of the following regimens before repeat colonoscopy:
- 4 liters of polyethylene glycol (PEG) plus 12 milligrams of bisacodyl
- 1 liter of PEG plus ascorbic acid plus 10 milligrams of bisacodyl
- 2 liters of PEG plus extra PEG taken over the 3 days before colonoscopy
- undergo repeat colonoscopy
- rate their satisfaction with the bowel preparation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants are randomly assigned in a 1:1:1 ratio to 1 of 3 rescue bowel preparation regimens before repeat colonoscopy after prior inadequate bowel preparation.
| Arm | Type | Receives |
|---|---|---|
| 4 L PEG + bisacodyl | Active comparator | Drug: DrugParticipants receive 4 L polyethylene glycol (PEG) plus bisacodyl 12 mg before repeat colonoscopy after prior inadequate bowel preparation. |
| 1 L PEG plus ascorbic acid + bisacodyl | Active comparator | Drug: DrugParticipants receive 1 L polyethylene glycol (PEG) plus ascorbic acid and bisacodyl 10 mg before repeat colonoscopy after prior inadequate bowel preparation. |
| 2 L PEG + additional PEG | Active comparator | Drug: DrugParticipants receive 2 L polyethylene glycol (PEG) plus additional PEG administered during the 3 days before repeat colonoscopy after prior inadequate bowel preparation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Prior inadequate bowel preparation (adequately performed) requiring repeat colonoscopy
- Scheduled to undergo repeat outpatient colonoscopy
- Ability to provide informed consent
Key exclusion criteria (6 listed)
- Age younger than 18 years
- Inability to provide informed consent
- Contraindication to any study bowel preparation regimen or colonoscopy
- Known or suspected bowel obstruction or severe gastrointestinal motility disorder
- Pregnancy or breastfeeding
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 |
|---|---|---|
| DrugAlso: SELG ESSE, Bisacodyl4 liters of polyethylene glycol plus bisacodyl 12 mg administered as rescue bowel preparation before repeat colonoscopy. | Drug | 4 L PEG + bisacodyl |
| DrugAlso: Plenvu, Bisacodyl1 liter of polyethylene glycol plus ascorbic acid and bisacodyl 10 mg administered as rescue bowel preparation before repeat colonoscopy. | Drug | 1 L PEG plus ascorbic acid + bisacodyl |
| DrugAlso: Clensia2 liters of polyethylene glycol plus additional polyethylene glycol administered during the 3 days before repeat colonoscopy. | Drug | 2 L PEG + additional PEG |
Primary outcome
Adequate bowel preparation at repeat colonoscopy
Time frame: At repeat colonoscopy, on the day of the procedure
Proportion of participants with adequate bowel preparation at repeat colonoscopy, defined as a Boston Bowel Preparation Scale (BBPS) total score of 6 or higher, with a score of at least 2 in each colonic segment.
6 secondary outcomes
Total Boston Bowel Preparation Scale score at repeat colonoscopy
Time frame: At repeat colonoscopy, on the day of the procedure
Right colon Boston Bowel Preparation Scale subscore
Time frame: At repeat colonoscopy, on the day of the procedure
Transverse colon Boston Bowel Preparation Scale subscore
Time frame: At repeat colonoscopy, on the day of the procedure
Left colon Boston Bowel Preparation Scale subscore
Time frame: At repeat colonoscopy, on the day of the procedure
Participant satisfaction with bowel preparation
Time frame: Assessed after bowel preparation and before or at repeat colonoscopy, on the day of the procedure
Polyp detection at repeat colonoscopy
Time frame: At repeat colonoscopy, on the day of the procedure
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 14 May 2026.
- Individual participant dataSharing planned: No
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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 Drug in people with Bowel Cleansing for Colonoscopy and Inadequate Bowel Preparation, run by Ospedale San Pio 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 May 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. 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?
Contact Giuseppe Scaglione (+39 360638237, giuseppe.scaglione@aornsanpio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate bowel preparation at repeat colonoscopy (time frame: At repeat colonoscopy, on the day of the procedure). 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 14 May 2026.