Colon CancerPhase 3NCT05726097
Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
A Phase 3 study testing polyethylene glycol, sodium phosphate and polyethylene glycol + ascorbic acid in people with Colon Cancer and Inflammatory Bowel Diseases, run by Region Skane at 1 site in Sweden.
Trial summary
The study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Inflammatory Bowel Diseases, Gastrointestinal Bleed
- What is being tested?
- polyethylene glycol, sodium phosphate and polyethylene glycol + ascorbic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2023to 31 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Subject referred for clinical colon/panenteric examination
- Subject received an explanation about the nature of the study and agreed to provide written informed consent
Who cannot join
- Subject with dysphagia or any swallowing disorder
- Subject with a prior stomach, small bowel, or colonic resection
- Subject with severe renal insufficiency
- Subject with any allergy or other known contraindication to the medications used in the study
- Women who are either pregnant or nursing
- Subject suffers from life threatening conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
The study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate.
Read the detailed description
Colon capsule endoscopy (CCE) is a promising modality for lower gastrointestinal (GI) investigations in clinical routine and screening. Furthermore, the double-headed camera capsules are being applied for panenteric investigations, with promising results. The major limitation to its use has been finding a bowel preparation that will clean the colon adequately for good visualization of the mucosa and help propel the capsule using boosters through the colon. To achieve wider CCE adoption, challenges regarding completion rates (CR) and adequate cleanliness rates (ACR) must be handled. CR and ACR should be improved to meet the standards for optical colonoscopy (OC) from the European Society of GI Endoscopy (ESGE). ESGE recommends both CR and ACR ≥ 90%. Recently, a meta-analysis of preparation regimens for CCE confirmed that CR and ACR were suboptimal.
This study is designed to investigate the CR, ACR, and diagnostic yield (DY) of very low-volume polyethylene glycol (PEG) - based laxative compared to a conventional high-volume laxative and the use of different boosters.
All consecutive patients referred for colon capsule endoscopy will be enrolled in the study. PillCam® Crohn's capsule will be used. Patients will undergo a split-dose bowel preparation with a very low-volume PEG-based laxative. In the study arm nr1 gastrografin and magnesiumoxid + sodium picosulfate will be used. In the study arm Nr 2, the same regimen will be used but completed with 2 mg of prucalopride before ingesting the capsule. The results of the study arms will be compared to the previously used standard regimen with 4 L of PEG as a laxative and sodium phosphate as a booster.
The images from the colon capsule will be reviewed, and the quality of bowel preparation (cleanliness rates) and completion rate will be evaluated. Patient tolerance of the bowel preparations and diagnostic yield of colon capsule endoscopy using the different preparation regimens will also be evaluated.
- Being tested
- polyethylene glycol, sodium phosphate, polyethylene glycol + ascorbic acid, gastrografin, magnesiumoxid + sodium picosulfate
- Keywords
- colon capsule endoscopy, panenteric capsule endoscopy, colon preparation
- Medical subject headings
- Colonic Neoplasms, Inflammatory Bowel Diseases, Gastrointestinal Hemorrhage, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycolDrug
Also called Laxabon
colonic preparation
sodium phosphateDrug
Also called Phosphoral
colonic preparation
polyethylene glycol + ascorbic acidDrug
Also called Plenvu
colonic preparation
gastrografinDrug
colonic preparation
magnesiumoxid + sodium picosulfateDrug
Also called Picoprep
colonic preparation
prucaloprideDrug
Also called Resolol
colonic preparation
| Study group | Role | What they receive |
|---|---|---|
| Standard preparation regimen | Active comparator | 4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster Receives: Drug: polyethylene glycol; Drug: sodium phosphate |
| Optimized preparation regimen | Experimental | 1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster Receives: Drug: polyethylene glycol + ascorbic acid; Drug: gastrografin; Drug: magnesiumoxid + sodium picosulfate |
| Optimized preparation regimen with prucalopride | Experimental | 1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride Receives: Drug: polyethylene glycol + ascorbic acid; Drug: gastrografin; Drug: magnesiumoxid + sodium picosulfate; Drug: prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness rate
Visualization of the hemorrhoidal plexus or an excreted capsule
Measured: Within 3 months after completed capsule colonoscopy
Adequate cleanliness rate
Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale
Measured: Within 3 months after completed capsule colonoscopy
Secondary outcomes (3)
Transit times
Determining the amount of time for the capsule to transit through the stomach, small bowel and large bowel for the different preparations
Measured: Within 3 months after completed capsule colonoscopy
Diagnostic yield
Findings in the small and large bowel
Measured: Within 3 months after completed capsule colonoscopy
Assessment of patient tolerance of the bowel preparations
Survey questionnaire to be completed by participants at the time of the colon capsule endoscopy assessing the tolerability of the preparation and side effects
Measured: Within 3 months after completed capsule colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Feb 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Ervin Toth, MD PhD, Principal investigator, Department of Gastroenterology, Skåne University Hospital, Malmö, Lund University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726097
- Sponsor's protocol ID
- 2022-06303-02
- Status last verified
- Feb 2024
- First submitted
- 22 Dec 2022
- Last updated
- 28 Feb 2024
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Bowel Preparation Regimen for Colon Capsule Endoscopy Procedure
- ClinicalTrials.gov ID
- NCT05726097
- Acronym / sponsor ID
- 2022-06303-02
- Keywords
- colon capsule endoscopy, panenteric capsule endoscopy, colon preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University, Odense University Hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 13 Feb 2023 (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 study aims to investigate the effect of the optimized bowel preparation and boost regimens on colon capsule endoscopy procedures, specifically on cleanliness and completion rate.
Detailed description
Colon capsule endoscopy (CCE) is a promising modality for lower gastrointestinal (GI) investigations in clinical routine and screening. Furthermore, the double-headed camera capsules are being applied for panenteric investigations, with promising results. The major limitation to its use has been finding a bowel preparation that will clean the colon adequately for good visualization of the mucosa and help propel the capsule using boosters through the colon. To achieve wider CCE adoption, challenges regarding completion rates (CR) and adequate cleanliness rates (ACR) must be handled. CR and ACR should be improved to meet the standards for optical colonoscopy (OC) from the European Society of GI Endoscopy (ESGE). ESGE recommends both CR and ACR ≥ 90%. Recently, a meta-analysis of preparation regimens for CCE confirmed that CR and ACR were suboptimal.
This study is designed to investigate the CR, ACR, and diagnostic yield (DY) of very low-volume polyethylene glycol (PEG) - based laxative compared to a conventional high-volume laxative and the use of different boosters.
All consecutive patients referred for colon capsule endoscopy will be enrolled in the study. PillCam® Crohn's capsule will be used. Patients will undergo a split-dose bowel preparation with a very low-volume PEG-based laxative. In the study arm nr1 gastrografin and magnesiumoxid + sodium picosulfate will be used. In the study arm Nr 2, the same regimen will be used but completed with 2 mg of prucalopride before ingesting the capsule. The results of the study arms will be compared to the previously used standard regimen with 4 L of PEG as a laxative and sodium phosphate as a booster.
The images from the colon capsule will be reviewed, and the quality of bowel preparation (cleanliness rates) and completion rate will be evaluated. Patient tolerance of the bowel preparations and diagnostic yield of colon capsule endoscopy using the different preparation regimens will also be evaluated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard preparation regimen | Active comparator | Drug: polyethylene glycol, Drug: sodium phosphate4 L polyethylene glycol as laxative 30 + 15 mL sodium phosphate as a booster |
| Optimized preparation regimen | Experimental | Drug: polyethylene glycol + ascorbic acid, Drug: gastrografin, Drug: magnesiumoxid + sodium picosulfate1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster |
| Optimized preparation regimen with prucalopride | Experimental | Drug: polyethylene glycol + ascorbic acid, Drug: gastrografin, Drug: magnesiumoxid + sodium picosulfate, Drug: prucalopride1 L polyethylene glycol + ascorbic acid as laxative and gastrografin and magnesiumoxid + sodium picosulfate as a booster + 2 mg of prucalopride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject referred for clinical colon/panenteric examination
- Subject received an explanation about the nature of the study and agreed to provide written informed consent
Key exclusion criteria (6 listed)
- Subject with dysphagia or any swallowing disorder
- Subject with a prior stomach, small bowel, or colonic resection
- Subject with severe renal insufficiency
- Subject with any allergy or other known contraindication to the medications used in the study
- Women who are either pregnant or nursing
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 |
|---|---|---|
| polyethylene glycolAlso: Laxaboncolonic preparation | Drug | Standard preparation regimen |
| sodium phosphateAlso: Phosphoralcolonic preparation | Drug | Standard preparation regimen |
| polyethylene glycol + ascorbic acidAlso: Plenvucolonic preparation | Drug | Optimized preparation regimen, Optimized preparation regimen with prucalopride |
| gastrografincolonic preparation | Drug | Optimized preparation regimen, Optimized preparation regimen with prucalopride |
| magnesiumoxid + sodium picosulfateAlso: Picoprepcolonic preparation | Drug | Optimized preparation regimen, Optimized preparation regimen with prucalopride |
| prucaloprideAlso: Resololcolonic preparation | Drug | Optimized preparation regimen with prucalopride |
Primary outcome
Completeness rate
Time frame: Within 3 months after completed capsule colonoscopy
Visualization of the hemorrhoidal plexus or an excreted capsule
Adequate cleanliness rate
Time frame: Within 3 months after completed capsule colonoscopy
Assessment of the quality of the bowel preparation using a the 4-point Leighton-Rex scale
3 secondary outcomes
Transit times
Time frame: Within 3 months after completed capsule colonoscopy
Diagnostic yield
Time frame: Within 3 months after completed capsule colonoscopy
Assessment of patient tolerance of the bowel preparations
Time frame: Within 3 months after completed capsule colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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. This study is not recruiting at the moment.
Ervin Toth, MD PhD principal investigator
Department of Gastroenterology, Skåne University Hospital, Malmö, Lund University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing polyethylene glycol, sodium phosphate and polyethylene glycol + ascorbic acid in people with Colon Cancer and Inflammatory Bowel Diseases, run by Region Skane at 1 site in Sweden.
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 2 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: finished, as of the sponsor's last update on 28 Feb 2024. 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 Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completeness rate (time frame: Within 3 months after completed capsule colonoscopy). The study lists 2 primary outcomes in all. 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 28 Feb 2024.