Short Peptide Formula for Bowel Preparation
Evaluation of Short Peptide Formula for Bowel Preparation in Video Capsule Endoscopy
1 other identifier
interventional
210
1 country
1
Brief 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. Investigators are aimed to prospectively assess the quality of bowel preparation in pediatric patients receiving short peptide diet versus those receiving liquid diet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2018
CompletedFirst Posted
Study publicly available on registry
November 15, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 17, 2020
February 1, 2020
12 months
November 13, 2018
February 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cleansing score
Cleansing scores were recorded according to a predetermined criterion
assessed through study completion, an average of 1 year
Secondary Outcomes (2)
Diagnostic yield
assessed through study completion, an average of 1 year
Completion rate
assessed through study completion, an average of 1 year
Other Outcomes (2)
Adverse events
assessed through study completion, an average of 1 year
Bristol scores
assessed through study completion, an average of 1 year
Study Arms (2)
Formula group
EXPERIMENTALshort peptide formula prior to capsule endoscopy
Control group
OTHERregular liquid diet
Interventions
Eligibility Criteria
You may qualify if:
- Indications of capsule endoscopy;
- Informed consent form obtained.
You may not qualify if:
- Contraindication of capsule endoscopy;
- Unwilling to participate;
- Formula allergy;
- Unable to swallow the capsule.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 201102, China
Related Publications (2)
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.
PMID: 26134966BACKGROUNDvan 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.
PMID: 18072052BACKGROUND
Study Officials
- STUDY DIRECTOR
Ying Huang, PhD
Children's Hospital of Fudan University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The director of gastroenterology of Children's Hospital of Fudan University
Study Record Dates
First Submitted
November 13, 2018
First Posted
November 15, 2018
Study Start
January 1, 2019
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share