Small Bowel DiseasePhase 4NCT02486536
The Best Dosage and Timing of Polyethylene Glycol for Bowel Preparation Before Capsule Endoscopy
A Phase 4 study testing polyethylene glycol and capsule endoscopy in people with Small Bowel Disease, run by Zhizheng Ge at 3 sites in China.
Trial summary
The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Bowel Disease
- What is being tested?
- polyethylene glycol and capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 3 sitesChina
- Study dates
- Jul 2015to Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 75 years and referred to capsule endoscopy because of suspected small-bowel disease are prospectively eligible for entry into the study.
Who cannot join
- Age < 18 or > 75 years
- Known or suspected GI stricture or fistula
- A history of GI tract resection
- Swallowing disorders
- Intensive therapy with fasting and parenteral nutrition;with a disease that may reduce movement of the GI tract, such as diabetes mellitus
- Medications that could affect gastrointestinal movement within one week
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- Implanted with a medical electronic device
- Active inflammatory bowel disease, toxic megacolon, toxic colitis
- Severe pulmonary, cardiac, renal, or hepatic disease
- Uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg);
- Disturbance of electrolytes
- Pregnancy or lactation
- Patients inability to provide written voluntary informed consent
- Participation in another clinical study
Trial locations and contacts
3 sites in 1 country.
China3 sites
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Tongren Hospital Affiliated to Shanghai Jiaotong University, China
Shanghai, Shanghai Municipality, 200050
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: The Best Dosage and Timing of PEG for Bowel Preparation Before Capsule Endoscopy a Prospective, Single-Blind, Randomized, Multi-center Study
The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination.
- Conditions
- Small Bowel Disease
- Being tested
- polyethylene glycol, capsule endoscopy
- Keywords
- capsule endoscopy, polyethylene glycol, bowel preparation solutions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycolDrug
capsule endoscopyDevice
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Fast for 12h before the examination and take 8ml of Simethicone Emulsion (Berlin-Chemie, Germany, containing 40 mg simethicone in 1mL emulsion) with 250ml water 30min before capsule ingestion.CE are performed with the Pillcam SB2 capsule endoscopy system (Given Imaging Co. Ltd., Yoqnem, Israel). Receives: Device: capsule endoscopy |
| Group B | Active comparator | the same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. Receives: Drug: polyethylene glycol; Device: capsule endoscopy |
| Group C | Active comparator | the same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. Receives: Drug: polyethylene glycol; Device: capsule endoscopy |
| Group D | Active comparator | Group D: the same as protocol A plus 1L Polyethylene glycol 3-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. Receives: Drug: polyethylene glycol; Device: capsule endoscopy |
| Group E | Active comparator | Group E: the same as protocol A plus 2L Polyethylene glycol 2-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. Receives: Drug: polyethylene glycol; Device: capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of visualization of the small bowel
The image quality was evaluated only in cases in which the capsule reached the cecum within the examination period. All CE images will be assessed at low speed (10 frames/s) under the AutoView mode of the RAPID workstation (Given Imaging). The intestinal mucosa is defined as clean if, less than 25% of the mucosal surface was covered by dark liquid, bubbles or debris. Using a timer, the investigators record the exact time period during which the small intestinal mucosa was clean. The definition of "excellent" is at least 90% of the overall small bowel mucosa is clean (the sum of "clean" time /total small bowel transit time>90%). And the definition of "good" is at least 80% of the overall small bowel mucosa is clean. We considered that "excellent" or "good" preparation is adequate to make an accurate diagnosis.
Measured: one week after CE procedure
Secondary outcomes (2)
patient acceptability
A visual analogical scale (VAS) is used to evaluate the degree of patients' discomfort. The numerical scale between 0 and 10, with 0 being no burden at all and 10 indicating an intolerable procedure.
The questionnaire provide information about whether they experienced nausea, bloating, or any discomfort during the bowel preparation, difficulty to complete the preparation, their willingness to repeat the same preparation in the future (yes or no)and did it affect their daily activity and nocturnal rest.
Measured: day of CE procedure
diagnostic rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Bowel DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhizheng Ge
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital, Shanghai East Hospital, Shanghai Tong Ren Hospital
- Responsible party
- Sponsor-investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486536
- Sponsor's protocol ID
- 2015-045k
- Status last verified
- Jun 2017
- First submitted
- 24 Jun 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu S, Zhong L, Zheng P, Wang YG, Ding WQ, Yu Q, Hui PP, Chen HM, Gao YJ, Ge ZZ. Low-dose and same day use of polyethylene glycol improves image of video capsule endoscopy: A multi-center randomized clinical trial. J Gastroenterol Hepatol. 2020 Apr;35(4):634-640. doi: 10.1111/jgh.14899. Epub 2019 Dec 15.
PubMed 31682026
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Best Dosage and Timing of PEG for Bowel Preparation Before Capsule Endoscopy a Prospective, Single-Blind, Randomized, Multi-center Study
- ClinicalTrials.gov ID
- NCT02486536
- Acronym / sponsor ID
- 2015-045k
- Conditions
- Small Bowel Disease
- Keywords
- capsule endoscopy, polyethylene glycol, bowel preparation solutions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Zhizheng GeUniversity, hospital or other
- Collaborators
- Huashan Hospital, Shanghai East Hospital, Shanghai Tong Ren Hospital
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 1 Jul 2015 (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.
The aim of this study is to evaluate the ideal dose of PEG and timing of bowel preparation in patients referred for CE examination.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: capsule endoscopyFast for 12h before the examination and take 8ml of Simethicone Emulsion (Berlin-Chemie, Germany, containing 40 mg simethicone in 1mL emulsion) with 250ml water 30min before capsule ingestion.CE are performed with the Pillcam SB2 capsule endoscopy system (Given Imaging Co. Ltd., Yoqnem, Israel). |
| Group B | Active comparator | Drug: polyethylene glycol, Device: capsule endoscopythe same as protocol A plus 1L Polyethylene glycol 11-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. |
| Group C | Active comparator | Drug: polyethylene glycol, Device: capsule endoscopythe same as protocol A plus 2L Polyethylene glycol 10-12h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. |
| Group D | Active comparator | Drug: polyethylene glycol, Device: capsule endoscopyGroup D: the same as protocol A plus 1L Polyethylene glycol 3-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. |
| Group E | Active comparator | Drug: polyethylene glycol, Device: capsule endoscopyGroup E: the same as protocol A plus 2L Polyethylene glycol 2-4h before VCE. CE are performed with the Pillcam SB2 capsule endoscopy system. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged between 18 and 75 years and referred to capsule endoscopy because of suspected small-bowel disease are prospectively eligible for entry into the study.
Key exclusion criteria (14 listed)
- Age < 18 or > 75 years
- Known or suspected GI stricture or fistula
- A history of GI tract resection
- Swallowing disorders
- Intensive therapy with fasting and parenteral nutrition;with a disease that may reduce movement of the GI tract, such as diabetes mellitus
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 glycol | Drug | Group B, Group C, Group D, Group E |
| capsule endoscopy | Device | Group A, Group B, Group C, Group D, Group E |
Primary outcome
the quality of visualization of the small bowel
Time frame: one week after CE procedure
The image quality was evaluated only in cases in which the capsule reached the cecum within the examination period. All CE images will be assessed at low speed (10 frames/s) under the AutoView mode of the RAPID workstation (Given Imaging). The intestinal mucosa is defined as clean if, less than 25% of the mucosal surface was covered by dark liquid, bubbles or debris. Using a timer, the investigators record the exact time period during which the small intestinal mucosa was clean. The definition of "excellent" is at least 90% of the overall small bowel mucosa is clean (the sum of "clean" time /total small bowel transit time>90%). And the definition of "good" is at least 80% of the overall small bowel mucosa is clean. We considered that "excellent" or "good" preparation is adequate to make an accurate diagnosis.
2 secondary outcomes
patient acceptability
Time frame: day of CE procedure
diagnostic rate
Time frame: one year
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 22 Jun 2017.
- Derived from this study: PubMed 31682026Wu S, Zhong L, Zheng P, Wang YG, Ding WQ, Yu Q, Hui PP, Chen HM, Gao YJ, Ge ZZ. Low-dose and same day use of polyethylene glycol improves image of video capsule endoscopy: A multi-center randomized clinical trial. J Gastroenterol Hepatol. 2020 Apr;35(4):634-640. doi: 10.1111/jgh.14899. Epub 2019 Dec 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing polyethylene glycol and capsule endoscopy in people with Small Bowel Disease, run by Zhizheng Ge at 3 sites in China.
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 1 inclusion and 14 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 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 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?
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?
the quality of visualization of the small bowel (time frame: one week after CE procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486536, which also lists 1 linked publication.
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 22 Jun 2017.