Colorectal PolypsPhase 4NCT02887573
Free-residue Nutrients for the Bowel Preparation of Colon Capsule Endoscopy
A Phase 4 study testing Free-residue nutrients, Low fiber diet and Colon capsule endoscopy in people with Colorectal Polyps, run by Kaichun Wu.
Trial summary
Colon capsule endoscopy(CCE) is a new diagnostic method of colonic lesions.It has advantages of no requirement for sedation and air insufflation.The bowel preparation has a closely relationship with yield of diagnosing diseases.Bowel preparation of CCE is not only to clean the colon but also to promote capsule… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Polyps
- What is being tested?
- Free-residue nutrients, Low fiber diet and Colon capsule endoscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jul 2017
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age.
- underwent a diagnostic OC that demonstrated colorectal polyps that required endoscopic treatment.
Who cannot join
- dysphagia/swallowing disorder
- prior major abdominal surgery of the gastrointestinal tract, known or suspected bowel obstruction
- cardiac pacemaker/implanted electromedical device
- pregnant or nursing women
- any allergy or contraindication to the drugs used in the study.
- refused to sign a informed consent.
About this study
Colon capsule endoscopy(CCE) is a new diagnostic method of colonic lesions.It has advantages of no requirement for sedation and air insufflation.The bowel preparation has a closely relationship with yield of diagnosing diseases.Bowel preparation of CCE is not only to clean the colon but also to promote capsule propulsion.Now there is not an optimal method for CCE.
Read the detailed description
Objective: In this study, a new bowel preparation regime of the colon capsule is used.This regime combines free-residue nutrients and polyethylene glycol (PEG) to achieve a better preparation quality.
Methods: Participants who underwent a diagnostic colonoscopy examination that demonstrated a colorectal polyps that required endoscopic treatment will be recruited to patients in the study. The first 32 participants receive a traditional low fiber diet two days before the test.Then the patients will take 2L polyethylene glycol (PEG) at 21:00-23:00 before the test day and 2L PEG at 05:00-07:00 on the test day for bowel preparation. The subsequent 30 participants receive two-days free-residue nutrients without other diet before the test.Then the patients will take 2L PEG at 05:00-07:00 on the examination day for bowel preparation. Then they will take 5mg mosapride citrate at 8:00 and ingest the colon capsule at 8:30.0.75L and 0.50L PEG are administered as boosters.And the therapeutic endoscopy will be given on the following day.Before the therapeutic colonoscopy, the participants will take 2L PEG. The colon capsule results will be reviewed by two experienced endoscopists who are blinded to first endoscopy results.
- Conditions
- Colorectal Polyps
- Being tested
- Free-residue nutrients, Low fiber diet, Colon capsule endoscopy, 2L PEG, 4L PEG
- Keywords
- Bowel preparation, Colorectal polyps, Colon capsule endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free-residue nutrientsDrug
This trial evaluated the efficiency of free-residue nutrients for the bowel prepartion of CCE.
Low fiber dietDrug
Low fiber diet often used in the bowel prepartion of CCE. In this study, it is the control group.
Colon capsule endoscopyProcedure or surgery
In the study,all patients should undergo two colonoscopies.The first is for examinations and the second for therapy.
2L PEGDrug
Also called polyethylene glycol
2L PEG are laxatives for experiment group.
4L PEGDrug
Also called polyethylene glycol
4L PEG are laxatives in the control group.
PEGDrug
Also called polyethylene glycol
These PEG are for boosters. All patients will take 0.75L and 0.5L PEG for two boosters.
Mosapride citrateDrug
5mg mosapride citrate are used to promote gastric motivity.
| Study group | Role | What they receive |
|---|---|---|
| Free-residue nutrients+PEG | Experimental | Diet: Free-residue nutrients Free-residue nutrient will be given when the patients are hungry before the two days of the capsule day.There are no other diet in this arm.
Drug: PEG 2L PEG are used at 05:00-07:00 the morning of the test. Drug: Mosapride citrate The patients will take 5mg mosapride citrate at 8:00. Drug:PEG 0.75L and 0.50L PEG are administered as boosters for patients. Procedure: Colon capsule endoscopy The colon capsule will be ingested at 08:30 the day of the test.The images will be reviewed by two experienced endoscopists.
Procedure: Colonoscopy On the following day of the test.All participants will undergo therapeutic colonoscopy. Receives: Drug: Free-residue nutrients; Procedure: Colon capsule endoscopy; Drug: 2L PEG; Drug: PEG; Drug: Mosapride citrate |
| Low fiber diet+PEG | Experimental | Diet: Low fiber diet Before the two days of the capsule day,when the patients hungry,low fiber diet wiil be given.
Drug: PEG 4L PEG are used at 21:00-23:00 the night before the test and 05:00-07:00 the morning of the test.
Drug: Mosapride citrate The patients will take 5mg mosapride citrate at 8:00. Drug:PEG 0.75L and 0.50L PEG are administered as boosters for patients. Procedure: Colon capsule endoscopy The colon capsule will be ingested at 08:30 the day of the test.The images will be reviewed by two experienced endoscopists.
Procedure: Colonoscopy On the following day of the test,All participants will undergo therapeutic colonoscopy. Receives: Drug: Low fiber diet; Procedure: Colon capsule endoscopy; Drug: 4L PEG; Drug: PEG; Drug: Mosapride citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Cleansing Level of Two Different Bowel Preparation Methods
The first 32 patients adopted a low fiber diet two days before the CCE procedure. Bowel preparation included the ingestion of 2L polyethyleneglycol in the evening before test day and 2L PEG in the morning on the test day. The subsequent 30 patients were received free-residue Nutrients。Then they ingested 2L PEG between 5:00 and 7.00 am of the examination day. The capsule was scheduled at 8:30 am. When the capsule reached the small bowel, 0.75L PEG was used as first booster. If the capsule had not been excreted 3 hours later, the patients was received 0.5L PEG.
Measured: an expected average of 1 months from study procedure
Secondary outcomes (4)
Accuracy parameters:assessment the yield of detection of polyps ≥6mm and ≥10mm;
Measured: an expected average of 1 months from study procedure
The gastrointestinal tract transit times and the colonic transit times between two different bowel preparation methods for CCE;
The gastrointestinal tract transit time was defined as the time from initial ingestion to capsule excretion. The colon transit time defined as first capsule image of the cecum to capsule excretion.
Measured: an expected average of 1 months from study procedure
Colon capsule excretion rate between two different bowel preparation methods;
Measured: an expected average of 1 months from study procedure
Adverse events between two different bowel preparation methods.
Measured: the PillCam procedure day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJan 2014
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaichun Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kaichun Wu, Xijing Hospital of Digestive Diseases
- Investigators
- Wu Kaichun, phD, Study director, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887573
- Sponsor's protocol ID
- XijingHDD
- Status last verified
- Feb 2017
- First submitted
- 20 Aug 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free-residue Nutrients for the Bowel Preparation of Colon Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT02887573
- Acronym / sponsor ID
- XijingHDD
- Conditions
- Colorectal Polyps
- Keywords
- Bowel preparation, Colorectal polyps, Colon capsule endoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Kaichun WuUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 2 Sep 2016 (estimated)
- 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.
Colon capsule endoscopy(CCE) is a new diagnostic method of colonic lesions.It has advantages of no requirement for sedation and air insufflation.The bowel preparation has a closely relationship with yield of diagnosing diseases.Bowel preparation of CCE is not only to clean the colon but also to promote capsule propulsion.Now there is not an optimal method for CCE.
Detailed description
Objective: In this study, a new bowel preparation regime of the colon capsule is used.This regime combines free-residue nutrients and polyethylene glycol (PEG) to achieve a better preparation quality.
Methods: Participants who underwent a diagnostic colonoscopy examination that demonstrated a colorectal polyps that required endoscopic treatment will be recruited to patients in the study. The first 32 participants receive a traditional low fiber diet two days before the test.Then the patients will take 2L polyethylene glycol (PEG) at 21:00-23:00 before the test day and 2L PEG at 05:00-07:00 on the test day for bowel preparation. The subsequent 30 participants receive two-days free-residue nutrients without other diet before the test.Then the patients will take 2L PEG at 05:00-07:00 on the examination day for bowel preparation. Then they will take 5mg mosapride citrate at 8:00 and ingest the colon capsule at 8:30.0.75L and 0.50L PEG are administered as boosters.And the therapeutic endoscopy will be given on the following day.Before the therapeutic colonoscopy, the participants will take 2L PEG. The colon capsule results will be reviewed by two experienced endoscopists who are blinded to first endoscopy results.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free-residue nutrients+PEG | Experimental | Drug: Free-residue nutrients, Procedure: Colon capsule endoscopy, Drug: 2L PEG, Drug: PEG, Drug: Mosapride citrateDiet: Free-residue nutrients Free-residue nutrient will be given when the patients are hungry before the two days of the capsule day.There are no other diet in this arm. Drug: PEG 2L PEG are used at 05:00-07:00 the morning of the test. Drug: Mosapride citrate The patients will take 5mg mosapride citrate at 8:00. Drug:PEG 0.75L and 0.50L PEG are administered as boosters for patients. Procedure: Colon capsule endoscopy The colon capsule will be ingested at 08:30 the day of the test.The images will be reviewed by two experienced endoscopists. Procedure: Colonoscopy On the following day of the test.All participants will undergo therapeutic colonoscopy. |
| Low fiber diet+PEG | Experimental | Drug: Low fiber diet, Procedure: Colon capsule endoscopy, Drug: 4L PEG, Drug: PEG, Drug: Mosapride citrateDiet: Low fiber diet Before the two days of the capsule day,when the patients hungry,low fiber diet wiil be given. Drug: PEG 4L PEG are used at 21:00-23:00 the night before the test and 05:00-07:00 the morning of the test. Drug: Mosapride citrate The patients will take 5mg mosapride citrate at 8:00. Drug:PEG 0.75L and 0.50L PEG are administered as boosters for patients. Procedure: Colon capsule endoscopy The colon capsule will be ingested at 08:30 the day of the test.The images will be reviewed by two experienced endoscopists. Procedure: Colonoscopy On the following day of the test,All participants will undergo therapeutic colonoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-80 years of age.
- underwent a diagnostic OC that demonstrated colorectal polyps that required endoscopic treatment.
Key exclusion criteria (6 listed)
- dysphagia/swallowing disorder
- prior major abdominal surgery of the gastrointestinal tract, known or suspected bowel obstruction
- cardiac pacemaker/implanted electromedical device
- pregnant or nursing women
- any allergy or contraindication to the drugs used in the study.
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 |
|---|---|---|
| Free-residue nutrientsThis trial evaluated the efficiency of free-residue nutrients for the bowel prepartion of CCE. | Drug | Free-residue nutrients+PEG |
| Low fiber dietLow fiber diet often used in the bowel prepartion of CCE. In this study, it is the control group. | Drug | Low fiber diet+PEG |
| Colon capsule endoscopyIn the study,all patients should undergo two colonoscopies.The first is for examinations and the second for therapy. | Procedure or surgery | Free-residue nutrients+PEG, Low fiber diet+PEG |
| 2L PEGAlso: polyethylene glycol2L PEG are laxatives for experiment group. | Drug | Free-residue nutrients+PEG |
| 4L PEGAlso: polyethylene glycol4L PEG are laxatives in the control group. | Drug | Low fiber diet+PEG |
| PEGAlso: polyethylene glycolThese PEG are for boosters. All patients will take 0.75L and 0.5L PEG for two boosters. | Drug | Free-residue nutrients+PEG, Low fiber diet+PEG |
| Mosapride citrate5mg mosapride citrate are used to promote gastric motivity. | Drug | Free-residue nutrients+PEG, Low fiber diet+PEG |
Primary outcome
Bowel Cleansing Level of Two Different Bowel Preparation Methods
Time frame: an expected average of 1 months from study procedure
The first 32 patients adopted a low fiber diet two days before the CCE procedure. Bowel preparation included the ingestion of 2L polyethyleneglycol in the evening before test day and 2L PEG in the morning on the test day. The subsequent 30 patients were received free-residue Nutrients。Then they ingested 2L PEG between 5:00 and 7.00 am of the examination day. The capsule was scheduled at 8:30 am. When the capsule reached the small bowel, 0.75L PEG was used as first booster. If the capsule had not been excreted 3 hours later, the patients was received 0.5L PEG.
4 secondary outcomes
Accuracy parameters:assessment the yield of detection of polyps ≥6mm and ≥10mm;
Time frame: an expected average of 1 months from study procedure
The gastrointestinal tract transit times and the colonic transit times between two different bowel preparation methods for CCE;
Time frame: an expected average of 1 months from study procedure
Colon capsule excretion rate between two different bowel preparation methods;
Time frame: an expected average of 1 months from study procedure
Adverse events between two different bowel preparation methods.
Time frame: the PillCam procedure day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Wu Kaichun, phD study director
Xijing Hospital of Digestive Diseases
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Free-residue nutrients, Low fiber diet and Colon capsule endoscopy in people with Colorectal Polyps, run by Kaichun Wu.
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: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Bowel Cleansing Level of Two Different Bowel Preparation Methods (time frame: an expected average of 1 months from study 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 7 Feb 2017.