Capsule EndoscopyNCT03742934
Short Peptide Formula for Bowel Preparation
A study testing Short peptide and Liquid diet in people with Capsule Endoscopy and Pediatric Disorder, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Video capsule endoscopy (VCE) is a noninvasive diagnostic tool used to assess the small bowel pathology. The diagnostic value of VCE is mostly dependent on the cleanliness of the colon. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Capsule Endoscopy, Pediatric Disorder
- What is being tested?
- Short peptide and Liquid diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Indications of capsule endoscopy;
- Informed consent form obtained.
Who cannot join
- Contraindication of capsule endoscopy;
- Unwilling to participate;
- Formula allergy;
- Unable to swallow the capsule.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Evaluation of Short Peptide Formula for Bowel Preparation in Video Capsule Endoscopy
Video capsule endoscopy (VCE) is a noninvasive diagnostic tool used to assess the small bowel pathology. The diagnostic value of VCE is mostly dependent on the cleanliness of the colon. Investigators are aimed to prospectively assess the quality of bowel preparation in pediatric patients receiving short peptide diet versus those receiving liquid diet.
- Conditions
- Capsule Endoscopy, Pediatric Disorder
- Being tested
- Short peptide, Liquid diet
- Keywords
- Bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short peptideOther
Short peptide formula during bowel preparation
Liquid dietOther
Liquid diet during bowel preparation
| Study group | Role | What they receive |
|---|---|---|
| Formula group | Experimental | short peptide formula prior to capsule endoscopy Receives: Other: Short peptide |
| Control group | Other | regular liquid diet Receives: Other: Liquid diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleansing score
Cleansing scores were recorded according to a predetermined criterion
Measured: assessed through study completion, an average of 1 year
Secondary outcomes (2)
Diagnostic yield
Percentage of positive cases
Measured: assessed through study completion, an average of 1 year
Completion rate
CE was considered complete when the cecum was reached within recording time
Measured: assessed through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Capsule EndoscopyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
- Investigators
- Ying Huang, PhD, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742934
- Sponsor's protocol ID
- PreparationVCE
- Status last verified
- Feb 2020
- First submitted
- 13 Nov 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goyal J, Goel A, McGwin G, Weber F. Analysis of a grading system to assess the quality of small-bowel preparation for capsule endoscopy: in search of the Holy Grail. Endosc Int Open. 2014 Sep;2(3):E183-6. doi: 10.1055/s-0034-1377521. Epub 2014 Jul 16.
PubMed 26134966van Tuyl SA, den Ouden H, Stolk MF, Kuipers EJ. Optimal preparation for video capsule endoscopy: a prospective, randomized, single-blind study. Endoscopy. 2007 Dec;39(12):1037-40. doi: 10.1055/s-2007-966988.
PubMed 18072052
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Short Peptide Formula for Bowel Preparation in Video Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT03742934
- Acronym / sponsor ID
- PreparationVCE
- Conditions
- Capsule Endoscopy, Pediatric Disorder
- Keywords
- Bowel preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 15 Nov 2018 (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.
Video capsule endoscopy (VCE) is a noninvasive diagnostic tool used to assess the small bowel pathology. The diagnostic value of VCE is mostly dependent on the cleanliness of the colon. Investigators are aimed to prospectively assess the quality of bowel preparation in pediatric patients receiving short peptide diet versus those receiving liquid diet.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formula group | Experimental | Other: Short peptideshort peptide formula prior to capsule endoscopy |
| Control group | Other | Other: Liquid dietregular liquid diet |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Indications of capsule endoscopy;
- Informed consent form obtained.
Key exclusion criteria (4 listed)
- Contraindication of capsule endoscopy;
- Unwilling to participate;
- Formula allergy;
- Unable to swallow the capsule.
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 |
|---|---|---|
| Short peptideShort peptide formula during bowel preparation | Other | Formula group |
| Liquid dietLiquid diet during bowel preparation | Other | Control group |
Primary outcome
Cleansing score
Time frame: assessed through study completion, an average of 1 year
Cleansing scores were recorded according to a predetermined criterion
2 secondary outcomes
Diagnostic yield
Time frame: assessed through study completion, an average of 1 year
Completion rate
Time frame: assessed through study completion, an average of 1 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 17 Feb 2020.
- Background: PubMed 26134966Goyal J, Goel A, McGwin G, Weber F. Analysis of a grading system to assess the quality of small-bowel preparation for capsule endoscopy: in search of the Holy Grail. Endosc Int Open. 2014 Sep;2(3):E183-6. doi: 10.1055/s-0034-1377521. Epub 2014 Jul 16.
- Background: PubMed 18072052van Tuyl SA, den Ouden H, Stolk MF, Kuipers EJ. Optimal preparation for video capsule endoscopy: a prospective, randomized, single-blind study. Endoscopy. 2007 Dec;39(12):1037-40. doi: 10.1055/s-2007-966988.
- Individual participant dataSharing planned: No
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Video Capsule Endoscopy, Esophageal Diseases
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.
Ying Huang, PhD study director
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short peptide and Liquid diet in people with Capsule Endoscopy and Pediatric Disorder, run by Children's Hospital of Fudan University at 1 site 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 2 inclusion and 4 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 17 Feb 2020. 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 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.
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?
Cleansing score (time frame: assessed through study completion, an average of 1 year). 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 NCT03742934, which also lists 2 linked publications.
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 17 Feb 2020; AzTrials last refreshed its copy on 29 Oct 2026.